Medical device, kit and method for constricting tissue or a bodily orifice, for example, a mitral valve

ABSTRACT

A device, kit and method may employ an implantable device (e.g., annuloplasty implant) and a tool to implant such. The implantable device is positionable in a cavity of a bodily organ (e.g., a heart) and operable to constrict a bodily orifice (e.g., a mitral valve). Tissue anchors are guided into precise position by an intravascularly deployed anchor guide frame and embedded in an annulus. Constriction of the orifice may be accomplished via a variety of structures, for example by cinching a flexible cable or anchored annuloplasty ring, the cable or ring attached to the tissue anchors. The annuloplasty ring may be delivered in a generally elongated configuration, and implanted in an anchored generally arch, arcuate or annular configuration. Such may move a posterior leaflet anteriorly and an anterior leaflet posteriorly, improving leaflet coaptation to eliminate mitral regurgitation.

BACKGROUND Field

This disclosure is generally related to percutaneous or minimallyinvasive surgery, and more particularly to percutaneously deployedmedical devices suitable for constricting tissue or a bodily orifice,such as a mitral valve.

Description of the Related Art

Cardiac surgery was initially undertaken only by performing asternotomy, a type of incision in the center of the chest, whichseparates the sternum (chest bone) to allow access to the heart. In theprevious several decades, more and more cardiac operations are performedusing a percutaneous technique, which is a medical procedure whereaccess to inner organs or other tissue is gained via a catheter.

Percutaneous surgeries benefit patients by reducing surgery risk,complications, and recovery time. However, the use of percutaneoustechnologies also raises some particular challenges. Medical devicesused in percutaneous surgery need to be deployed via narrow tubes calledcatheter sheaths, which significantly increase the complexity of thedevice structure. As well, doctors do not have direct visual contactwith the medical tools used once they are placed within the body, andpositioning the tools correctly and operating the tools successfully canoften be very challenging. Various catheters can be deployed through acatheter sheath in percutaneous surgical applications.

One example of where percutaneous medical techniques are starting to beused is in the treatment of a heart disorder called mitralregurgitation. Mitral regurgitation is a condition in which blood flowsbackward from the left ventricle into the left atrium. The mitralapparatus is made up of four major structural components and includesthe annulus, the two leaflets, the chordae and the papillary muscles.Improper function of any one of these structures, alone or incombination can lead to mitral regurgitation. Annular dilation is amajor component in the pathology of mitral regurgitation regardless ofcause and is manifested in mitral regurgitation related to dilatedcardiomyopathy and chronic mitral regurgitation due to ischemia.

The mitral valve is intended to prevent the undesired flow of blood fromthe left ventricle into the left atrium when the left ventriclecontracts. In a normal mitral valve, the geometry of the mitral valveensures the cusps overlay each other to preclude the regurgitation ofblood during left ventricular contraction and thereby prevent elevationof pulmonary vascular pressures and resultant symptoms of shortness ofbreath. Studies of the natural history of mitral regurgitation havefound that totally asymptomatic patients with severe mitralinsufficiency usually progress to severe disability within 5 years.

At present, treatment consists of either mitral valve replacement orrepair. Both methods require open heart surgery. Replacement can beperformed with either mechanical or biological valves and isparticularly suitable when one of the mitral cusps has been severelydamaged or deformed. The mechanical valve carries the risk ofthromboembolism and requires anticoagulation with all of its potentialhazards, whereas the biological prosthesis suffers from limiteddurability. Another hazard with replacement is the risk of endocarditis.These risks and other valve related complications are greatly diminishedwith valve repair. Mitral valve repair is theoretically possible if themitral valve leaflets are structurally normal but fail to appropriatelycoapt because of annular dilatation and/or papillary muscle dysfunction.Various surgical procedures have been developed to improve coaptation ofthe leaflet and to correct the deformation of the mitral valve annulusand retain the intact natural heart valve function. These proceduresgenerally involve reducing the circumference of the posterior mitralleaflet annulus (lateral annulus) where most of the dilatation occurs.The annulus of the anterior leaflet (septal annulus) does not generallydilate because it is anchored to the fibrous skeleton at the base of theheart. Such techniques, known as mitral annuloplasty, typically suture aprosthesis around the base of the valve leaflets shortening the lateralannulus to reshape the mitral valve annulus and minimize furtherdilation. Different types of mitral annuloplasty prostheses have beendeveloped for use in such surgery. In general, such prostheses areannular or partially annular shaped and may be formed from rigid orflexible material.

Mitral valve surgery requires an extremely invasive approach thatincludes a chest wall incision, cardiopulmonary bypass, cardiac andpulmonary arrest, and an incision on the heart itself to gain access tothe mitral valve. Such a procedure is expensive, requires considerabletime, and is associated with high morbidity and mortality. Due to therisks associated with this procedure, many of the sickest patients aredenied the potential benefits of surgical correction of mitralregurgitation. In addition, patients with moderate, symptomatic mitralregurgitation are denied early intervention and undergo surgicalcorrection only after the development of cardiac dysfunction.Furthermore, the effectiveness of such procedures is difficult to assessduring the procedure and may not be known until a much later time.Hence, the ability to make adjustments to or changes in the prosthesisfunction to obtain optimum effectiveness is extremely limited.Correction at a later date would require another open heart procedure.

In an attempt to treat mitral regurgitation without the need forcardiopulmonary bypass and without opening the chest, percutaneousapproaches have been devised to repair the valve or place a correctingapparatus for correcting the annulus relaxation. Such approaches makeuse of devices which can be generally grouped into two types: 1) devicesdeforming (mainly shortening) the coronary sinus; and 2) devices pullingtogether two anchor points in order to affect the mitral valve, one ofthe anchor points can be the coronary sinus (typically using a wire thatis pulled and secured).

Neither approach emulates the current “gold standard” in mitral valverepair—annuloplasty using an open or closed ring. Both approaches sufferfrom several problems as a result of attempting to reshape the mitralannulus using an alternative method. Devices that deform the coronarysinus, while suitable for percutaneous procedures, are not effective incontrolling the leakage of the mitral valve as the forces are notapplied from the correct opposite sides of the valve, which are thelateral annulus and the septal annulus. The devices of the second typeare not easily adapted to a percutaneous procedure. In order to achieveshortening in the direction connecting the lateral annulus to the septalannulus the anchor points have to be located along this line, so pullingthem together will affect the desired direction of shortening. Pullingapplied along a different direction will distort the mitral valve butwill not achieve the optimal approximation of the two leaflets.

Thus, there is a need for methods and apparatus that enable the abilityto create a mitral annuloplasty that applies forces from various desireddirections via a percutaneous or intravascular procedure.

BRIEF SUMMARY

The subject of the present application is a medical device with enhancedcapabilities for percutaneous deployment and annulus shape modificationand a superior method for constricting tissue or a bodily orifice, suchas the mitral valve, tricuspid valve, or aortic valve via such device.The device may enable methods that enable a closed or open (i.e., split)ring to be anchored to tissue in the vicinity of an orifice or annulusand may enable a change in the shape of said annulus by the anchoredring. Reference throughout this specification is made to cardiacsurgery, but the methods and apparatus described herein may also be usedin gastric surgery, bowel surgery, or other surgeries in which tissuemay be drawn together. The methods and apparatus described herein mayalso be used to draw or hold tissue not part of an orifice or annulustogether. The methods and apparatus described herein may be used inminimally invasive surgery as well as intravascular or percutaneoussurgery. Other advantages will become apparent from the teaching hereinto those of skill in the art.

An implant kit may be summarized as including a plurality of tissueanchors comprising at least a first tissue anchor, a second tissueanchor and a third tissue anchor; a percutaneous delivery systemoperable to at least partially embed each of the tissue anchors into arespective location about a periphery of an orifice in a tissue within abody during an implant procedure in which a location of the embeddedthird tissue anchor is laterally offset by a first distance from a firstaxis, the first axis extending between a location of the embedded firsttissue anchor and a location of the embedded second tissue anchor; animplant member reconfigurable between a delivery configuration in whichthe implant member is manipulable to a size and dimension to bedeliverable percutaneously to the tissue within the body, and animplantable configuration in which the implantable member forms astructure sufficiently rigid to affect a shape of the orifice in thetissue, the implant member further comprising a plurality of tissueanchor receivers, each of the tissue anchor receivers positioned tophysically couple with a respective one of the embedded tissue anchors,the plurality of tissue anchor receivers comprising at least a firsttissue anchor receiver corresponding to the first tissue anchor, asecond tissue anchor receiver corresponding to the second tissue anchor,and a third tissue anchor receiver corresponding to the third tissueanchor, wherein a location of the third tissue anchor receiver on theimplant member in the implantable configuration is laterally offset by asecond distance from a second axis, the second axis extending between alocation of the first tissue anchor receiver on the implant member and alocation of the second tissue anchor receiver on the implant member,wherein the second distance is smaller than the first distance; and aplurality of implant guide lines that in use during the implantprocedure provide a physical path for the implant member to the embeddedtissue anchors.

The implant member may include a plurality of segments physicallycoupled to one another, the segments being articuable with respect toone another as the implant member is moved between the deliverableconfiguration and the implantable configuration. The implant member mayinclude a number of hinges that physically couple each of the segmentsto at least one other of the segments. The implant member may include anumber of stops configured to increase a torsional stiffness of each ofthe hinges when each of the segments pivots by a defined amount withrespect to another of the segments. The implant member may include anumber of flexure joints that physically couple each of the segments toat least one other of the segments. The implant member may include anumber of stops configured to increase a bending stiffness of each ofthe flexure joints when each of the segments flexes by a defined amountwith respect to another of the segments. The implant member may includea number of stops configured to restrain articulation between thecoupled segments.

Each of the tissue anchors may include at least one barb. Each of thetissue anchors may be a helical tissue anchor. Each of the tissueanchors may be a grapple tissue anchor, each grapple tissue anchor mayinclude at least two prongs pivotally coupled to each other, and each ofthe two prongs may have a tip shaped to pierce the tissue.

The implant member may have at least three guide line receivers thateach ride on respective ones of the guide lines, wherein a circumferencedefined by a circle passing through at least three locations of the atleast three guide line receivers on the implant member in theimplantable configuration may be smaller than a circumference defined bya circle passing through the respective locations of the embedded first,second and third tissue anchors prior to a physical coupling betweeneach of the embedded first, second and third tissue anchors andrespective ones of the first, second and third tissue anchor receivers.

An implant kit may be summarized as including an implant memberconfigured to affect a shape of an orifice in tissue within a bodyduring an implant procedure, a portion of the implant member having avariable bending stiffness in at least one dimensional plane, theimplant member comprising a first end, a second end and a plurality ofguide line receivers positioned between the first end and the second endalong the implant member, the implant member configured to be bendablebetween a first configuration in which implant member has an elongatedshape and a second configuration in which the implant has an arcuateshape, the first end being spaced apart from the second end by a greaterdistance when the implant member is in the first configuration than whenthe implant member is in the second configuration, and the portion ofthe implant member having a reduced bending stiffness in the at leastone dimensional plane when the implant member is in first configurationand an increased bending stiffness in the at least one dimensional planewhen the implant member is in the second configuration; a plurality oftissue anchors configured to be at least partially embedded into tissueat respective locations about the orifice in the tissue within the body;and a plurality of guide lines, each of the guide lines sized to bereceived by a respective one of the guide line receivers and arespective one of the tissue anchors, each of at least one of the guidelines being configured to receive a tensile force sufficient to move aportion of the tissue into which a respective tissue anchor is embeddedtowards the implant member in the second configuration.

The implant member may include a plurality of tissue anchor receiverspositioned along the implant member between the first end and the secondend, each of the tissue anchor receivers configured to physicallyreceive a respective one of the tissue anchors, and wherein each of theat least one of the guide lines may be configured to receive a tensileforce sufficient to move the portion of the tissue to a position wherethe respective tissue anchor embedded into the portion of the tissue isphysically received by a respective tissue anchor receiver when theimplant member in the second configuration.

The implant member may include a plurality of segments physicallycoupled to one another, the segments being articuable with respect toone another to provide the reduced bending stiffness in the at least onedimensional plane when the implant member is in the first configuration.The implant member may include a number of hinges that physically coupleeach of the segments to at least one other of the segments. The implantmember may include a number of stops configured to increase a torsionalstiffness of each of the hinges when each of the segments pivots by adefined amount with respect to another of the segments to provide theincreased bending stiffness in the at least one dimensional plane whenthe implant member is in the second configuration. The implant membermay include a number of flexure joints that physically couple each ofthe segments to at least one other of the segments. The implant membermay include a number of stops configured to provide the increasedbending stiffness in the at least one dimensional plane when the implantmember is in the second configuration. The implant member may include anumber of stops configured to restrain articulation between the coupledsegments to provide the increased bending stiffness in the at least onedimensional plane when the implant member is in the secondconfiguration.

The embedded tissue anchors may apply tension to implant member in thesecond configuration when each of the tissue anchor receivers is coupledwith a respective one of the embedded tissue anchors. The appliedtension may be sufficient to restrain disengagement of each of thecoupled segments with an associated one of the stops. The appliedtension may be sufficient to flex at least one of segments while each ofthe at least one of the segments is engaged with an associated one ofthe stops.

Each of the tissue anchors may include at least one piercing elementconfigured for piercing the tissue. Each of the tissue anchors may be ahelical tissue anchor. Each of the tissue anchors may be a grappletissue anchor, each grapple tissue anchor may include at least twoprongs pivotally coupled to each other, and each of the two prongs mayhave a tip shaped to pierce the tissue. The plurality of guide linereceivers may include at least three guide line receivers, acircumference defined by a circle passing through at least threelocations of the at least three guide line receivers on the implantmember in the second configuration being smaller than a circumferencedefined by a circle passing through at least three locations of theirrespective embedded tissue anchors about the orifice in the tissue priorto a physical coupling between any of the tissue anchor receivers andtheir respective embedded tissue anchors.

The implant member in the first configuration may be manipulable to asize and dimension to be deliverable via a catheter. The portion of theimplant member may have a substantially equal bending stiffness in eachof a plurality of directions in the at least one dimensional plane whenthe implant member is in the first configuration and the portion of theimplant member may have a substantially unequally bending stiffness ineach of the plurality of directions in the at least one dimensionalplane when the implant member is in the second configuration.

An implant kit may be summarized as including a plurality of tissueanchors configured to be at least partially embedded into tissue atrespective locations about an orifice in the tissue during an implantprocedure; an implant member having a plurality of segments physicallycoupled to one another, in a delivery configuration the segments beingarticulable with respect to one another by a respective articulationjoint such that the implant member is manipulable to a size anddimension to be deliverable via a catheter and in an deployedconfiguration the segments form a structure sufficiently rigid to affecta shape of the orifice in the tissue when the implant member ispositioned to physically couple with the embedded tissue anchors; and aplurality of implant guide lines that in use during the implantprocedure provide a physical path for the implant member to respectiveones of the embedded tissue anchors, the implant member movable alongthe physical path to a position where the implant member is secured tothe tissue under tension in the deployed configuration.

The tissue anchors and respective ones of the guide lines may beintegral structures comprised of at least one of a metal wire. Thetissue anchors and respective ones of the guide lines may be unitarystructures, each of the tissue anchors may include at least one piercingelement at a distal end of a respective one of the guide lines, whereinthe at least one piercing element may be configured to pierce thetissue. The structure formed by the segments of the implant member mayhave a C-shape profile.

The implant kit may further include an implant cross connectorattachable across an open portion of the implant member such that whenattached, the implant cross connector and the structure formed by thesegments of the implant member have a D-shape profile.

The implant member may have a number of guide line receivers that rideon respective ones of the guide lines. The implant member may have atleast three guide line receivers, at least a first guide line receiverproximate a first end of the implant member, a second guide linereceiver proximate a second end of the implant member, and a third guideline receiver positioned along the structure formed by the segmentsbetween the first and the second guide line receivers.

The respective articulation joint of the implant member may include anumber of hinges that physically couple each of the segments of theimplant member to at least one other of the segments of the implantmember.

The implant member may include a number of stops configured to limit atravel of each of the segments of the implant member with respect toanother of the segments of the implant member. The implant member mayinclude a number of stops configured to increase a torsional stiffnessof each of the hinges when each of the segments of the implant memberpivots by a defined amount with respect to another of the segments ofthe implant member.

The respective articulation joint of the implant member may include anumber of flexure joints that physically couple each of the segments ofthe implant member to at least one other of the segments of the implantmember.

The implant member may include a number of stops configured to limit atravel of each of the segments of the implant member with respect toanother of the segments of the implant member. The implant member mayinclude a number of stops configured to increase a bending stiffness ofeach of the flexure joints when each of the segments of the implantmember flexes by a defined amount with respect to another of thesegments of the implant member.

The implant kit may further include an anchor guide frame having atleast three anchor guide arms, wherein each of the tissue anchors may beconfigured to be physically releasably guided by a respective one of theanchor guide arms of the anchor guide frame to a respective location onan annulus about the orifice in the tissue and embedded in the annulusat least proximate the respective locations.

The anchor guide arms may each include an outer tube having at least afirst outer tube lumen, and an inner tube having an inner tube lumen,the inner tube received in the first outer tube lumen of the outer tubefor translational movement between a retracted position in which adistal end of the inner tube does not extend beyond a distal end of thefirst outer tube lumen and an extended position in which the distal endof the inner tube extends beyond the distal end of the first outer tubelumen, the inner tube lumen of the inner tube receiving a respective oneof the guide lines for translation with respect thereto.

The distal end of the inner tube may be in butting engagement with aportion of a respective one of the tissue anchors until the inner tubeis withdrawn from the tissue anchor after the tissue anchor has beenembedded in the tissue.

The tissue anchors may each include at least one resilient barb, the atleast one resilient barb protectively retained in the inner tube lumenof the inner tube until the inner tube is withdrawn from the tissueanchor after the tissue anchor has been embedded in the tissue.

The outer tube of each of the anchor guide arms may further have asecond outer tube lumen; and the anchor guide frame may further includea plurality of arms, each of the arms received in the second outer tubelumen of a respective one of the anchor guide arms.

The implant member may have at least three guide line receivers thateach ride on respective ones of the guide lines, wherein a circumferencedefined by a circle passing through at least three locations of the atleast three guide line receivers on the implant member in the deployedconfiguration may be smaller than a circumference defined by a circlepassing through at least three locations of the embedded tissue anchorsin the tissue prior to a physical coupling between the implant memberand the embedded tissue anchors.

The implant member may have at least three guide line receivers thateach ride on respective ones of the guide lines, wherein a circumferencedefined by a circle passing through at least three locations of the atleast three guide line receivers on the implant member in the deployedconfiguration may be smaller than a circumference of an annulus of theorifice in the tissue prior to a physical coupling between the implantmember and the embedded tissue anchors.

The implant member may have at least three tissue anchor receivers, eachof the tissue anchor receivers positioned to physically couple with arespective one of the plurality of tissue anchors, wherein acircumference defined by a circle passing through at least threelocations of the at least three tissue anchor receivers on the implantmember in the deployed configuration may be smaller than a circumferencedefined by a circle passing through at least three locations of theembedded tissue anchors in the tissue prior to a physical couplingbetween the implant member and the embedded tissue anchors.

At least one of the tissue anchors may include a helical tissue anchor.The at least one of the tissue anchors may include a grapple tissueanchor that may include at least two prongs pivotally coupled to eachother, each of the two prongs having a tip shaped to pierce the tissue.

The implant kit may further include a plurality of fasteners, eachfastener movable along a respective one of the guide lines to a positionwhere at least some of the fasteners secure the implant member to thetissue under tension in the deployed configuration. Each of thefasteners may include a unidirectional clutch that in use allows thefastener to advance along a respective one of the guide lines toward arespective one of the embedded tissue anchors and prevents the fastenerfrom retreating along the guide line away from the respective embeddedtissue anchor. The plurality of fasteners and the implant member may beprovided in a unitary structure. The at least some of the fasteners mayeach be fastenable to a respective one of the guide lines to secure theimplant member to the tissue under tension in the deployedconfiguration. The at least some of the fasteners may each be fastenableto a respective one of the embedded tissue anchors to secure the implantmember to the tissue under tension in the deployed configuration.

The implant member may include a plurality of receivers, each of thereceivers having at least one of the guidelines passing therethrough,where all of the guidelines passing through a respective one of thereceivers extend to a single respective one of the tissue anchorsembedded in the tissue.

A tissue anchor system for securing an implant member to tissue within abody during an implant procedure may be summarized as including a tissueanchor comprising plurality of elongated members, each of the elongatedmembers comprising a first end, a second end and an intermediate portionpositioned between the first and the second ends, wherein each of thesecond ends comprises a tip shaped to penetrate the tissue, and theintermediate portions of at least two of the elongate members arepivotably coupled together by a pivot member; and at least one couplerphysically coupled to at least one of the elongated members at locationon a portion of the at least one of the elongated members extendingbetween the pivot point and the first end of the at least one of theelongated members, the coupler configured to securely couple the tissueanchor to the implant member during the implant procedure.

Each elongated member of the at least two elongated members may includean arcuate shaped portion. Each elongated member of the at least twoelongated members may include a portion between the pivot point and thesecond end of the elongated member that extends along an arcuate path.Each of the second ends may include a barb. The at least one coupler maybe physically coupled to each of the at least two elongated members. Theat least one coupler may include a flexible line sized to be receivedthrough an opening provided in an elongated member of the at least twoelongated members. The at least one coupler may include a flexible linesized to be received through a respective opening provided in eachelongated member of the at least two elongated members. The at least onecoupler may include a plurality of a flexible lines, each of theflexible lines sized to be received through an opening provided in anelongated member of the at least two elongated members. The at least onecoupler and the at least one elongated member may be a unitarystructure. The at least one coupler may include a flexible line sized tobe received though an opening provided in the at least one elongatedmember and through an opening provided in the implant member.

An opening may be provided in each of one or more of the elongatedmembers, each opening sized to receive a guide line therethrough.

The at least one coupler may include a clamp configured to clamp aportion of the implant member. The at least one coupler may include anextension sized to be received within an opening provided in the implantmember. The at least one coupler may include an expansion memberconfigured to expand and grip one or more surfaces of the implantmember. The at least one coupler may include a contraction memberconfigured to contract and grip one or more surfaces of the implantmember. The at least one coupler may include a detent. Each of thetissue anchor and the coupler may be sized to be deliveredpercutaneously to the tissue in the body during the implant procedure.

A method of operating a medical device system to constrict an orifice intissue may be summarized as including positioning a tool having a guideframe with a plurality of guide members such that distal ends of theguide members are at least proximate respective locations about aperiphery of an orifice in a tissue internally within a body; actuatingthe guide members to embed a plurality of tissue anchors in the tissueat least proximate respective ones of the respective locations about theperiphery of the orifice in the tissue; advancing an annuloplastyimplant member to the tissue along a plurality of guide lines thatextend from the embedded tissue anchors; and securing the annuloplastyimplant member to the embedded tissue anchors via a plurality offasteners, the annuloplasty implant secured in an anchoredconfiguration.

The method of operating a medical device system to constrict an orificein tissue may further include percutaneously delivering the guide frameinto the body in a compressed configuration; expanding the guide frameinto an uncompressed configuration before positioning the tool such thatthe distal ends of the guide members are at least proximate theirrespective locations about the periphery of the orifice; compressing theguide frame after actuating the guide members to embed the plurality oftissue anchors; and percutaneously removing the guide frame from thebody after compressing the guide frame.

The method of operating a medical device system to constrict an orificein tissue may further include percutaneously delivering the annuloplastyimplant member into the body in an unanchored configuration afterpercutaneously removing the guide frame from the body.

Securing the annuloplasty implant member to the embedded tissue anchorsvia a plurality of fasteners, the annuloplasty implant secured in ananchored configuration may include securing the annuloplasty implantmember in an arch shape anchored proximate each of two ends, andproximate a location between the two ends, and percutaneously deliveringthe annuloplasty implant member into the body in an unanchoredconfiguration comprises percutaneously delivering the annuloplastyimplant member in an elongated scallop shape.

The method of operating a medical device system to constrict an orificein tissue may further include passing the guide lines through respectiveones of a number of guide line receivers of the annuloplasty implantmember before percutaneously delivering the annuloplasty implant memberinto the body in an unanchored configuration.

Actuating the guide members to embed a plurality of tissue anchors inthe tissue at least proximate respective ones of the respectivelocations about the periphery of the orifice in the tissue may includeembedding the tissue anchors such that a circumference defined by acircle passing through at least three locations of respective ones ofthe tissue anchors embedded about the periphery of the orifice in thetissue is greater than a circumference defined by a circle passingthrough at least three locations of the guide line receivers on theannuloplasty member in the anchored configuration. Actuating the guidemembers to embed a plurality of tissue anchors in the tissue may includeactuating the guide members to embed the plurality of tissue anchorshaving respective ones of the guide lines extending therefrom in thetissue.

Securing the annuloplasty implant member to the embedded tissue anchorsvia a plurality of fasteners, the annuloplasty implant secured in ananchored configuration may include advancing each fastener along arespective one of the guide lines into contact with a respective portionof the annuloplasty implant member. Securing the annuloplasty implantmember to the embedded tissue anchors via a plurality of fasteners, theannuloplasty implant secured in an anchored configuration may includeadvancing each fastener having a unidirectional clutch along arespective one of the guide lines.

Actuating the guide members to embed a plurality of tissue anchors inthe tissue at least proximate respective ones of the respectivelocations about the periphery of the orifice in the tissue may includeextending a respective inner tube of each of the guide members from alumen of a respective outer tube of each of the guide members, the innertube advancing a respective one of the tissue anchors into the tissue.

The method of operating a medical device system to constrict an orificein tissue may further include withdrawing the inner tube of each of theguide members away from a respective one of the tissue anchors embeddedin the tissue to expose at least one barb of the tissue anchor to thetissue.

The method of operating a medical device system to constrict an orificein tissue may further include retracting the inner tube of each of theguide members into the lumen of the outer tube of the respective one ofthe guide members while at least maintaining a position of the guidewire extending from a respective one of the tissue anchors with respectto the tissue.

An annuloplasty implant may be summarized as including at least threearcuate segments coupled to one another by respective ones of a numberof articulation joints to form an articulated structure, each of thearcuate segments arcuate about a respective axis, the articulatedstructure having a first end and a second end, a first guide linereceiver proximate the first end, a second guide line receiver proximatethe second end, and at least a third guide line receiver between thefirst and the second guide line receivers, the first, the second and atleast the third guide line receivers each sized to receive a respectiveguide line to a respective tissue anchor, the articulated structureconfigurable between an anchored configuration in which the arcuatesegments are arranged with respect to one another in an arcuate shapestructure which is arcuate about an axis that is parallel to therespective axes of the arcuate segments, the arcuate shape structurehaving an anchored maximum longitudinal dimension and an anchoredmaximum lateral dimension, and an unanchored configuration in which thearcuate segments are arranged with respect to one another in anelongated scallop shape structure that has an unanchored maximumlongitudinal dimension and an unanchored maximum lateral dimension, theunanchored maximum longitudinal dimension greater than the anchoredmaximum longitudinal dimension and the anchored maximum lateraldimension greater than the unanchored maximum lateral dimension.

The articulation joints may be hinges that pivotally couple successivelyneighboring ones of the arcuate segments together in at least theunanchored configuration. The arcuate segments may each include a stopthat interacts with a complimentary stop on an adjacent one of thearcuate segments. A pin of each hinge may be offset from a longitudinalcenterline of at least one of the arcuate segments coupled by the hinge.The articulation joints may be flexure joints that pivotally couplesuccessively neighboring ones of the arcuate segments together in atleast the unanchored configuration. At least one respective recessbetween each pair of adjacent ones of the arcuate segments may defineeach of the respective flexure joints.

The arcuate segments may be configured to be mounted directly to tissuecomprising a mitral valve via a plurality of tissue anchors and guidelines that apply force to at least some of the arcuate segments as theannuloplasty implant transitions from the unanchored configuration tothe anchored configuration, the articulated structure sufficiently rigidwhen in the anchored configuration to affect a shape of the mitralvalve.

The annuloplasty implant may further include at least three fasteners,the fasteners each having an aperture sized to receive a respectiveguide line, and the fasteners sized to not be received through the guideline receivers of the arcuate segments.

The arcuate segments may include at least one of a textured surface, atissue scaffold or a therapeutic eluting layer. The articulatedstructure may be configured to be coupled directly to a plurality oftissue anchors embedded in tissue comprising an orifice, and wherein thearticulated structure may include at least three tissue anchorreceivers, each of the at least three tissue anchor receivers configuredto physically couple with a respective one of the tissue anchors, andwherein a circumference defined by a circle passing through at leastthree locations of the at least three tissue anchor receivers on thearticulated structure in the anchored configuration is smaller than acircumference defined by a circle passing through at least threelocations of the embedded tissue anchors in the tissue prior to aphysical coupling between the articulated structure and the embeddedtissue anchors.

Various systems and methods may include combinations and subsets ofthose summarized above.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, identical reference numbers identify similar elementsor acts. The sizes and relative positions of elements in the drawingsare not necessarily drawn to scale. For example, the shapes of variouselements and angles are not drawn to scale, and some of these elementsare arbitrarily enlarged and positioned to improve drawing legibility.Further, the particular shapes of the elements as drawn, are notintended to convey any information regarding the actual shape of theparticular elements, and have been solely selected for ease ofrecognition in the drawings.

FIG. 1 is a schematic diagram of a medical device system according toone illustrated embodiment, including an implantable device and a toolwith a control handle, tissue anchors, and anchor guide mechanism thatis operable to implant the implantable device.

FIG. 2 is a cutaway diagram of a heart showing an implantable medicaldevice implanted in tissue therein according to one illustratedembodiment, the implantable device percutaneously placed in a leftatrium of the heart.

FIG. 3 is a diagram showing an example of a helical tissue anchoraccording to one illustrated embodiment.

FIG. 4A is an isometric partial view showing an example of amulti-barbed tissue anchor with resilient barbs retained by aconstriction tube according to one illustrated embodiment.

FIG. 4B is an isometric partial view showing an example of amulti-barbed anchor with the resilient barbs free of the constrictiontube and exposed.

FIG. 5A is front elevational view showing a helical tissue anchorembedded in tissue according to one illustrated embodiment.

FIG. 5B is front elevational view showing a barbed tissue anchorembedded in tissue according to one illustrated embodiment.

FIG. 5C is front elevational view showing a barbed tissue anchor with anintegral guide line such as a guide wire according to anotherillustrated embodiment, the tissue anchor embedded in tissue.

FIG. 5D is front elevational view showing a barbed tissue anchor with aunitary guide line such as a guide wire according to a furtherillustrated embodiment, the tissue anchor embedded in tissue.

FIG. 5E is front elevational view showing a grapple tissue anchorembedded in tissue according to one illustrated embodiment.

FIG. 6A is an elevational view showing a tissue anchor movably receivedon a guided member according to one illustrated embodiment.

FIG. 6B is an elevational view showing a tissue anchor movably receivedon a guided rail according to another illustrated embodiment.

FIGS. 7A-7C are sequential elevational views showing a helical tissueanchor movably received on a guided member penetrating tissue at threesuccessive intervals of time according to one illustrated embodiment.

FIGS. 8A and 8B are sequential elevational views showing a multi-barbedtissue anchor movably received on a guided member penetrating tissue attwo successive intervals of time according to one illustratedembodiment.

FIGS. 8C through 8F are sequential elevational views showing amulti-barbed tissue anchor movably guided via a guided memberpenetrating tissue at four successive intervals of time according to oneillustrated embodiment.

FIG. 9 is an isometric view of an anchor guide frame according to oneillustrated embodiment.

FIG. 10 is a side elevational view of an anchor guide frame compressedinto a sheath according to one illustrated embodiment.

FIG. 11 is an isometric view of an expanded anchor guide frame accordingto one illustrated embodiment.

FIG. 12 is an isometric view showing a distal end of a medical devicesystem according to one illustrated embodiment

FIG. 13 is a cutaway diagram of a heart showing an example of tissueanchors secured in a mitral valve annulus according to one illustratedembodiment.

FIG. 14 is a cutaway diagram of a heart showing an example of tissueanchors and a cable used to constrict a mitral valve annulus accordingto one illustrated embodiment.

FIGS. 15A and 15B are cross-sectional views of a tool to secure a cableof an implantable device that constricts a bodily orifice at twosuccessive intervals of time illustrating a time prior to cutting thecable and a time when the cable is being cut according to oneillustrated embodiment.

FIGS. 16A and 16B are sequential isometric views showing a portion of acatheter with side slots according to one illustrated embodiment

FIG. 17 is a cross-sectional partial view of a mechanism according toone illustrated embodiment for holding a tissue anchor captive.

FIGS. 18A and 18B are successive side elevational views of a mechanismaccording to one illustrated embodiment for restricting a tissue anchorfrom release until the tissue anchor is fully embedded in tissue.

FIG. 19A is an isometric view of an implant member according to oneillustrated embodiment, the implant member shown in a deliveryconfiguration.

FIG. 19B is a top plan view of the implant member of FIG. 19A shown inthe delivery configuration.

FIG. 19C is an isometric view of the implant member of FIGS. 19A and19B, the implant member shown in an implantable configuration.

FIG. 19D is a front elevational view of the implant member of FIGS.19A-19C, shown in the implantable configuration.

FIG. 20A is an isometric view of an implant member according to anotherillustrated embodiment, the implant member shown in a deliveryconfiguration.

FIG. 20B is a top plan view of the implant member of FIG. 20A shown inthe delivery configuration.

FIG. 20C is an isometric view of the implant member of FIGS. 20A and20B, the implant member shown in an implantable configuration.

FIG. 20D is a front elevational view of the implant member of FIGS.20A-20C, shown in the implantable configuration.

FIG. 20E is a top plan view showing an implant cross member, accordingto one illustrated embodiment.

FIG. 21A is an isometric view of a fastener that fastens to a guideline, according to one illustrated embodiment FIG. 21B is across-sectional view of the fastener and guide line of FIG. 21A.

FIG. 22A is an isometric view of a fastener that fastens a guide line toa tissue anchor, according to another illustrated embodiment

FIG. 22B is a cross-sectional view of the fastener, guide line andtissue anchor of FIG. 22A.

FIG. 22C is an isometric view of an implant member that has singlepiece, unitary part fasteners that fastens a guide line to a tissueanchor, according to another illustrated embodiment

FIGS. 23A-23T are sequential schematic diagrams showing an implantprocedure according to one illustrated embodiment, which includesplacement of tissue anchors via an anchor guide frame at selectedlocations in an annulus surrounding a mitral valve of a left atrium of aheart and the securement of an implant member to the annulus via thetissue anchors.

FIG. 23U a schematic diagram showing an implant member in the form of anannuloplasty ring attached to an annulus of a mitral valve via tissueanchors, guide wires and fasteners, according to one illustratedembodiment.

FIG. 24A is an isometric view of an implant member according to anotherillustrated embodiment, the implant member shown in a deliveryconfiguration.

FIG. 24B is an isometric view of the implant member of FIG. 24A shownmated with a plurality of tissue anchors.

FIG. 24C shows a plurality of tissue anchors embedded in a tissueaccording to an illustrated embodiment.

FIG. 24D shows an implant member coupled with the embedded tissueanchors of FIG. 24C.

FIG. 24E is a sectional exploded view of a portion of the implant memberof FIGS. 24A and 24B prior to a mating with an embedded tissue anchor.

FIG. 24F is a sectional view of a portion of the implant member of FIGS.24A and 24B mated with an embedded tissue anchor.

FIG. 24G is an exploded isometric view of a portion of the implantmember of FIG. 24A and a grapple tissue anchor.

FIG. 24H is an isometric view of a portion of the implant member of FIG.24A mated with a grapple tissue anchor.

DETAILED DESCRIPTION

In the following description, certain specific details are set forth inorder to provide a thorough understanding of various embodiments of theinvention. However, one skilled in the art will understand that theinvention may be practiced without these details. In other instances,well-known structures have not been shown or described in detail toavoid unnecessarily obscuring descriptions of the embodiments of theinvention.

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure or characteristicdescribed in connection with the embodiment is included in at least oneembodiment of the present invention. Thus, the appearances of thephrases “in one embodiment” or “in an embodiment” in various placesthroughout this specification are not necessarily all referring to thesame embodiment. Furthermore, the particular features, structures, orcharacteristics may be combined in any suitable manner in one or moreembodiments.

As used in this specification and the appended claims, the singularforms “a,” “an,” and “the” include plural referents unless the contentclearly dictates otherwise. It should also be noted that the term “or”is generally employed in its sense including “and/or” unless the contentclearly dictates otherwise.

The headings provided herein are for convenience only and do notinterpret the scope or meaning of the claimed invention.

Overview of Device and Orifice Constriction Methods

Various embodiments of medical apparatus which are percutaneously orintravascularly deployed and may be used for constricting a bodilyorifice are described herein.

FIG. 1 shows a medical device system 100 including an implantable device115 and tool 116 to implant the implantable device 115, according to oneillustrated embodiment.

The tool 116 of the medical device system 100 may be used to deploy theimplantable device 115 having tissue anchors 107 and a flexible cable111. The tissue anchors 107 may be secured to the annulus of an orificeand the flexible cable 111 may be used to constrict the orifice bypulling the anchors 107 inward. The tool 116 of the medical devicesystem 100 comprises a flexible anchor guide frame 108 that may be usedto guide tissue anchors 107 of the implantable device to targetpositions on the orifice annulus. The anchor guide frame 108 may be madeof a material such as Nitinol. The anchor guide frame 108 shown in FIG.1 is comprised of three guide members, for instance guide wires 112,—one guide member for each of the tissue anchors 107 shown. The guideframe 108 may include a different number of guide members or arms (e.g.,guide wires or guide rails) if more tissue anchors are desired. Theguide members 112 shown preferably have hinges 113 and may be connectedwith small loops 109. The hinges 113 and loops 109 enable the guideframe 108 to fold up to fit inside a catheter and to expand to extendacross an orifice. Both the hinges 113 and loops 109 may be replaced byother mechanisms or structures that enable bending or compression. Thetool 116 of the medical device system 100 typically has an articulationmechanism 106 (e.g., a plurality of articulation joints) that enablescorrectly orienting the anchor guide frame 108 during deployment oftissue anchors 107. The articulation mechanism 106 is preferably able tobend in any direction. The tool 116 of the medical device system 100 mayinclude control knobs 103 and 104 which may be used to control thebending of the articulation mechanism 106 via cables that are carried inlong flexible tube 105.

Long flexible tube 105 extends from the articulation mechanism 106 to amedical device control mechanism 114 located at a proximal end of thecatheter. Control mechanism 114 may include control knobs 103 and 104,elongated release members (e.g., rods or wires) 101, push tubes 102, andguide wires 112. Additional controls may be included in otherembodiments. The flexible tube 105 may have multiple lumens. Multi-lumenpush tubes 102, guide members (e.g., guide wires) 112, release members101, cable 111, and other mechanisms may be carried in flexible tube105. In the illustrated embodiment, each push tube 102 has two lumens. Aguide wire 112 is carried in a first lumen and a release member 101 iscarried in a second lumen. Anchors 107 are attached at distal tips ofrelease members 101. The tissue anchor 107 may be inserted into theannulus of an orifice by advancing the push tube 102 along the guidemember 112 and advancing or rotating the release member 101 carried inthe push tube 102 at the same rate. The tissue anchor 107 may advancepast the hinge 113 and embed into the annulus of the orifice to beconstricted while in an unretracted configuration. Once the tissueanchor 107 is embedded, the release member 101 attached to the anchormay be retracted while the push tube 102 is held in place in a retractedconfiguration. Retraction of the release member 101 causes the tissueanchor 107 to detach from the distal tip of the release member 101 andremain embedded in the tissue at least proximate a desired location.Other embodiments may use different methods and/or structures to releasethe tissue anchors 107.

FIG. 2 shows an implantable device 207, 210 implanted in a portion of aheart to constrict a bodily orifice, for example a mitral valve of theheart, according to one illustrated embodiment.

A portion of the medical device system 100 may be percutaneously and/orintravascularly inserted into a portion of a heart 212, for example in aleft atrium 206 of the heart 212. In this example embodiment, a flexibleanchor guide frame 214 and implantable device are delivered via acatheter 202 inserted via the inferior vena cava 204 and penetrating thetransatrial septum 213 from a right atrium 203. The catheter 202 ispreferably less than 8 mm in diameter.

The flexible anchor guide frame 214 expands after being delivered viathe catheter 202 into a shape that preferably enables the tissue anchors207 of the implantable device to be delivered to the desired respectivepositions on the mitral annulus 209. The flexible anchor guide frame 214may be moved into the correct orientation by adjusting a shape of anarticulation mechanism 205, advancing or retracting flexible tube 201,or rotating flexible tube 201. The flexible anchor guide frame 214preferably has an overall shape that enables the frame to take on adesired orientation within a cavity by conforming to the shape or beingaffected by the movement of anatomical features. Such a property isknown as “self-locating”. Minimal insertion force and operator guidanceis typically needed to properly position the anchor guide mechanism. Theflexible anchor guide frame 214 may also have specific features whichcause the flexible anchor guide frame 214 to orient correctly based onthe position of an anatomical feature, such as the mitral valve cusps orleaflets 211. An example of such a feature is alignment fin 215.Alignment fin 215 is attached rigidly to flexible anchor guide frame 214and shaped so that it may be deflected to a particular orientation by ananatomical feature, such as mitral valve leaflets 211. As the flexibleanchor guide frame 214 is advanced toward an anatomical feature, such asthe mitral valve annulus 209, the shape or motion of an anatomicalfeature, such as the mitral valve leaflets 211, may cause alignment fin215, and thus attached flexible anchor guide frame 214, to rotate ortranslate to a desired orientation or location.

The tissue anchors 207 may be inserted into the annulus 209 by advancingthe push tubes 216 along the guide members (e.g., guide wires or rails)112. The tissue anchors 207 may advance past the bend 208 and embed intothe annulus 209. The embedded tissue anchors 207 may then be releasedfrom the push tubes 216. The flexible cable 210 connecting the tissueanchors 207 may then be tightened and secured to constrict the mitralannulus 209.

FIG. 3 shows an example of a tissue anchor according to one illustratedembodiment.

The tissue anchor 301 has a helical structure with sharp tip 303, andhence is denominated as a helical tissue anchor 301. Loop 302 may beused to connect to a structure to hold the tissue anchor 301 to arelease rod. Loop 302 may also be used to attach tissue anchor 301 to acable used for cinching the annulus of a bodily orifice.

FIGS. 4A and 4B show an example of a tissue anchor according to oneillustrated embodiment.

In particular, FIG. 4A shows the tissue anchor 403 in a compressedconfiguration, while FIG. 4B shows the tissue anchor 406 in an expandedconfiguration. The tissue anchors 403, 406 comprise multiple barbs 408(not shown in FIG. 4A), which may be resilient. The multiple barbs 408may be compressed into constriction tube 404 as shown for tissue anchor403. Compression of barbs 408 into constriction tube 404 enables theanchor to move more readily through a catheter and also to be insertedmore readily into tissue without causing damage to the tissue.

Tissue anchor 403 may include a hole 409 that may be used to attach theanchor to a cable 401 used for cinching the annulus of a bodily orifice.Constriction tube 404 may include a slot 402 to allow anchor 403 to beejected from constriction tube 404 in the case where hole 409 is mountedon a protruding flange.

Tissue anchor 406 may include a hole 407 that may be used to connectsaid anchor to release rod 405. Release rod 405 may be carried in alumen of push tube 410. If constriction tube 404 is extended over hole407 as shown for anchor 403, release rod 405 is held captive in hole 407by the wall of tube 404. If constriction tube 404 is retracted so as tonot cover hole 407, as shown for tissue anchor 406, release rod 405 isnot held captive in hole 407 and said tissue anchor may becomedisconnected from constriction tube 404 and release rod 405.

Tissue anchor 406 may be disconnected from release rod 405 and barbs 408may be uncompressed by retracting constriction tube 404 relative to therelease rod 405 and tissue anchor 406. Retracting constriction tube 404past the tips of barbs 408 causes said barbs to be released andresiliently expand. Retracting constriction tube 404 past hole 407 mayrelease tissue anchor 406.

FIGS. 5A-5E show examples of five types of tissue anchors embedded intissue.

In particular, FIG. 5A shows a helical anchor 501 embedded in tissue502. The helical tissue anchor 501 is embedded in tissue 502 by rotatingthe helical tissue anchor 501 about is longitudinal axis. FIG. 5B showsa multi-barbed anchor 505 embedded in tissue 502. The multi-barbedtissue anchor 505 is embedded in tissue 502 by pushing the anchor intothe tissue. Barbs 504 provide resistance to restrict the tissue anchor505 from being extracted. FIG. 5C shows a tissue anchor 510 withmultiple barbs 512 (only one called out in FIG. 5C) and an integralguide line or guide wire 514 embedded in tissue 502. The barbs 512 andguide line 514 may be secured in a shell 516 of the tissue anchor 510.For example, the barbs 512 and guide line or guide wire 514 may besecured via swaging. The guide line 514 may take a variety of forms, forexample a metal wire such as Nitinol. FIG. 5D shows a tissue anchor 520with multiple barbs 522 (only one called out in FIG. 5D) and a unitaryguide line or guide wire 524 embedded in tissue 502. In contrast to theembodiment of FIG. 5C, the embodiment of FIG. 5D forms the tissue anchor520 and guide line or guide wire 524 from a single piece of material,for instance a thin flexible metal wire, which is selected from metalsthat are biocompatible (e.g., stainless steel, Nitinol).

FIG. 5E shows a grapple tissue anchor 530 implanted into tissue 502.Grapple tissue anchor 530 includes a plurality of elongated members 535.At least two of the elongated members (i.e., first elongated member 535a and second elongated member 535 b in this example embodiment) arepivotably coupled together by pivot member 539. Each of the elongatedmembers 535 includes a first end 536, a second end 537, an intermediateportion 538 and a respective length along the elongated member 535extending between the first end 536 and the second end 537. Each secondend 537 includes a tip 540 shaped to penetrate tissue 502. In someexample embodiments, each second end 537 includes a barb. In thisexample embodiment, each of the elongated members 535 is an arcuateelongated member. In this example embodiment, each of the elongatedmembers 535 forms a prong. Pivot member 539 allows the elongated members535 to pivot with respect to one another to space tips 540 apart fromone another into a configuration advantageous for penetrating tissue502. Upon further deployment of grapple tissue anchor 530 into tissue502, the elongated members 535 are pivoted to draw tips 540 towards eachother which causes tips 540 to travel along a path through tissue 502such that tips 540 are positioned closer to one another than duringtheir initial deployment into tissue 502. This allows grapple tissueanchor 530 to firmly anchor itself into tissue 502. In this exampleembodiment, the plurality of elongated members 530 is physically coupledto a plurality of flexible lines 542 a and 542 b (collectively 542).Specifically, flexible line 542 a is coupled to elongated member 535 aand flexible line 542 b is physically coupled to elongated member 535 b.In this example embodiment, elongated member 535 a includes an opening544 a sized to receive flexible line 542 a and elongated member 535 bincludes an opening 544 b sized to receive flexible line 542 b. In someexample embodiments, a single flexible line 542 is received in anopening provided in each of the elongate members 535. In this exampleembodiment, the flexible lines 542 are guide lines. In some exampleembodiments, the flexible lines 542 and respective ones of the elongatemembers 535 are provided as a unitary structure.

FIGS. 6A and 6B show examples of tissue anchors guided by a guide memberin the form of a guide rail.

In particular, FIG. 6A shows a multi-lumen push tube 600 that may slideover a guide rail 601. Tissue anchor 602 may be temporarily attached tomulti-lumen push tube 600 by constriction tube 606 and a release rod(not shown). Sliding push tube 600 along guide rail 601 enables tissueanchor 602 to be controllably delivered to a location proximate to guiderail 601. Tissue anchor 602 may be constructed or oriented in such a waythat tissue anchor tip 607 slides along or very near to guide rail 601.Such orientation or construction enables the tip to be protected fromobstructions in the catheter or body that may dull the tip. Also, suchorientation or construction protects areas of tissue proximate the guiderail from inadvertent, damaging contact with the sharp tip 607 of tissueanchor 602.

FIG. 6B shows a single-lumen push tube 603 that may slide over guiderail 601. Helical tissue anchor 604 also may slide over guide rail 601and may be temporarily attached to single-lumen push tube 603 by latchmechanism 609. Latch mechanism 609 may be fastened to tissue anchor 604by a friction fitting that is released under sufficient axial force.This assembly enables tissue anchor 604 to be controllably delivered toa location proximate to guide rail 601. Tissue anchor 604 may beconstructed or oriented in such a way that tissue anchor tip 608 slidesalong or very near to guide rail 601. Such orientation or constructionenables the tip of the tissue anchor 604 to be protected fromobstructions in the catheter or body that may dull the tip. Also, suchorientation or construction protects areas of tissue proximate the guiderail 601 from inadvertent, damaging contact with the sharp tip of tissueanchor 608.

While FIGS. 6A and 6B show examples of two particular types of tissueanchors being guided by a rail, it will be apparent to those skilled inthe art that many other types of tissue anchors could also be deployedwith the aid of a guide rail as well.

FIGS. 7A-7C illustrates deployment of helical tissue anchors implantedor embedded in tissue according to one illustrated embodiment.

In particular, FIG. 7A shows a helical tissue anchor 702 partiallydeployed into tissue 708. The location that tissue anchor 702 enters thetissue may be determined by the position of a guide member, for instanceguide rail 704. Bend 707 in guide rail 704 may be positioned at theapproximate location where the tissue anchor 702 is to be deployed intothe tissue. Bend 707 in guide rail 704 may comprise a hinge, a flexure,or one of many other joints. Tissue anchor 702 is deployed by rotatingpush tube 703. The rotation of tissue anchor 702 at the position of thebend 707 causes tissue anchor 702 to spiral off guide rail 704 and intotissue 708.

FIG. 7B shows a helical tissue anchor 705 fully deployed into tissue708, but still connected to latch mechanism 709. In the fully deployedposition, helical tissue anchor 705 may no longer wrap around guide rail704. When still connected to latch mechanism 709, the helical tissueanchor 705 may be readily retracted by counter-rotating push tube 703.

FIG. 7C shows a helical tissue anchor 706 fully deployed into tissue 708and disconnected from to latch mechanism 709. Latch mechanism 709 maybecome disconnected from tissue anchor 706 by retracting push tube 703or releasing latch mechanism 709 with the addition of another cable totrigger a release mechanism.

FIGS. 8A and 8B show deployment of multi-barbed tissue anchors in tissueaccording to one illustrated embodiment.

In particular, FIG. 8A shows a multi-barbed tissue anchor 805 fullyinserted into tissue 804, but still encapsulated or retained byconstriction tube 809. The location that the multi-barbed tissue anchor805 enters the tissue may be determined by the position of a guidemember, for instance guide rail 803. A bend 810 in guide rail 803 may bepositioned at the approximate location where the multi-barbed tissueanchor 805 is to be deployed into the tissue 804. The bend 810 in guiderail 803 may be constructed using a hinge, a flexure, or one of manyother methods. The multi-barbed tissue anchor 805 is deployed byadvancing push tube 802 over guide rail 803. If encapsulated or retainedby constriction tube 809, multi-barbed tissue anchor 805 may be readilyretracted by retracting push tube 802.

FIG. 8B shows a multi-barbed tissue anchor 808 fully inserted intotissue 804, but disconnected from constriction tube 811 and releasemember 806. The multi-barbed tissue anchor 808 is preferably retractedslightly before release member 806 is disconnected in order to causebarbs 807 to expand. The multi-barbed tissue anchor 808 may bedisconnected from release member 806 and barbs 807 may be expanded byretracting constriction tube 809 relative to the release member 806 andmulti-barbed tissue anchor 808. Retracting constriction tube 811 pastthe tips of barbs 807 causes the resilient barbs to be released andexpand.

FIGS. 8C through 8F show a tissue anchor 820 movably guided to tissue824 and penetrating the tissue 824 at four successive intervals of time,according to one illustrated embodiment.

In particular, FIG. 8C shows a guide member portion of an anchor guideframe 826 of a tool initially contacting the tissue 824.

The guide member portion of the anchor guide frame 826 includes an outertube 828 having two lumens 830 a, 830 b. The guide member portionincludes an engagement or locating member 832. The engagement orlocating member 832 is used to physically engage the tissue 824 suchthat the anchor guide frame 826 is at a desired location and orientationin a bodily organ. The engagement or locating member 832 is movinglycarried in one lumen 830 a of the outer tube 828. The anchor guide frame826 includes an inner or guide tube 834 movingly received in the otherlumen 830 b of the outer tube 828. The guide tube 834 functions to guidethe tissue anchor 820 to a desired location on the tissue 824. A lumen836 of the guide tube 834 carries a guide wire 838. The guide wire 838is a thin flexible wire, for example a thin Nitinol wire. The guide wire838 may include a lubricous coating or layer, such aspolytetrafluoroethylene. The guide tube 834 provides lateral support forthe guide wire 838 and retains barbs 840 if the tissue anchor 820 is ina protected, contracted configuration. A butt end of the guide tube 834may physically engage or bear against an end or lip of the tissue anchor820. Thus, when the guide tube 834 and guide wire are pushed, the motionis effectively delivered to the tissue anchor 820, which will advanceout of the outer tube 828 along with the inner or guide tube 834. Theguide tube 834 may optionally be reinforced with one or more wires, forinstance Nitinol wires. The guide wire 838 is attached to the tissueanchor 820 and functions as a guide line for an implant member (notshown in FIGS. 8C-F), as described in detail further below.

In particular, FIG. 8D shows the tissue anchor 820 being embedded in thetissue 824, along with a portion of the guide tube 834 and guide wire838. FIG. 8E shows the guide tube 834 partially withdrawn from aroundthe tissue anchor 820, exposing the barbs 840 of the tissue anchor 820.In going from FIG. 8D to FIG. 8E, the guide wire 838 is pushedrelatively toward the tissue 824 while the guide tube 834 is pulled ordrawn away from the tissue 824. Pushing the guide wire 838 suppliesenough force to retain the tissue anchor 820 in the tissue 824 againstany force exerted by way of withdrawal of the guide tube 834. As theguide tube 834 clears the barbs 840, the barbs 840 expand due to theresiliency of the material from which the barbs 840 are fashioned. Thetissue anchor 820 is thus secured within the tissue 824.

FIG. 8F shows the tissue anchor 820 and guide wire 838 which remainafter the portion of the anchor guide frame 826 is withdrawn. The guidetube 834 may be fully retracted into the lumen 830 b of the outer tubeor catheter 828 prior to withdrawal of the anchor guide frame 826 fromthe bodily organ. As explained in detail below, the guide wire 838 maybe used to guide an implant member (e.g., annuloplasty ring) to thetissue 824, and/or to secure the implant member to the tissue 824 at adesired position and orientation.

While illustrated with two tubes per anchoring location, someembodiments may employ three tubes per anchoring location or more. Usingonly two tubes per anchoring location advantageously increases theflexibility of the catheter(s) relative to embodiments employing morethan two tubes per anchor location. Such eases the movement of thecatheter through the bodily lumen (e.g., artery). Such may also allowthe use of catheters with smaller diameters than would otherwise benecessary to accommodate one or more additional tubes per anchoringlocation.

FIG. 9 shows an example of an anchor guide frame of a tool according toone illustrated embodiment.

An anchor guide frame 901 is used to guide tissue anchors of the implantdevice to correct insertion or anchor points or locations. The anchorguide frame 901 shown comprises three guide members, for instance rails905, but said guide frame may comprise more or fewer guide members. Theanchor guide frame 901 embodiment illustrated shows all guide rails 905connected at the bottom of the guide frame 901. An anchor guide frame isnot required to have all guide members connected together, although itis often preferable to do so to create a guide frame that enables tissueanchors to be positioned relative to each other and to anatomicalfeatures. Thus, an anchor guide frame may have multiple disconnectedgroups of connected guide wires.

The anchor guide frame 901 preferably is capable of folding to enabledelivery via a catheter. Guide members (e.g., guide wires or rails) 905may be hinged at bends 902 and guide connection point 904 to enablefolding. Loop 903 facilitates folding and also acts as a spring toenable unfolding of the anchor guide frame 901.

Guide members 905 may be formed to have respective bends 906 when noexternal forces are being applied. When guide members 905 are carried ina catheter with an articulation mechanism shaped into a curve as shownin FIG. 2, the forces exerted on the guide member by the catheter andarticulation mechanism will cause bend 906 to align with the curve inthe articulation mechanism. Such alignment causes anchor guide frame 901to rotate to a desired position relative to the catheter orientation.Bend 906 may also be formed to assist in curving the articulationmechanism in a particular way.

An anchor guide frame may also contain additional features which useanatomical features or movement to assist in orientation of said anchorguide mechanism or guide frame 901. An example of such a feature is analignment fin 907. Alignment fin 907 is attached rigidly to flexibleanchor guide frame 901 and shaped so that the alignment fin 907 may bedeflected by an anatomical feature, such as mitral valve leaflets, to aparticular orientation. As the flexible anchor guide frame 901 isadvanced toward an anatomical feature, such as the mitral valve annulus,the shape or motion of an anatomical feature, such as the mitral valveleaflets, may cause alignment fin 907, and thus flexible anchor guideframe 901, to rotate to a desired orientation.

FIG. 10 shows an anchor guide frame folded for delivery inside acatheter according to one illustrated embodiment.

An anchor guide frame including guide members (e.g., guide wires orrails) 1004 may be folded inside a catheter sheath 1001. Hinges 1006 andloop 1007 enhance folding of the anchor guide mechanism. In theembodiment illustrated, tissue anchors 1003 fit between the guidemembers 1004 in the folded configuration. Protective anchor cap 1005holds and covers the sharp tips of tissue anchors 1003 and may ensurethat the tips do not catch or embed on the sides of catheter sheath1001. Protective anchor cap 1005 may be held in place by control wire1002

FIG. 11 shows an anchor guide frame in an expanded configurationaccording to one illustrated embodiment.

An anchor guide frame 1112 may self expand after exiting catheter sheath1111. In particular, the anchor guide frame 1112 may be formed of aresilient material or a shape memory material such as Nitinol. Loop 1106may be formed to cause the anchor guide frame 1112 to expand. Hinges1105 facilitate separation of guide members 1104 by about 20 mm to 45mm. In the illustrated embodiment, tissue anchors 1109 are held withinthe volume encompassed by anchor guide frame 1112 which ensures thetissue anchors 1109 do not accidentally impinge tissue. Also, the tipsof the tissue anchors are held captive within protective anchor cap1110. The tips of the tissue anchors may be released by advancingcontrol wire 1103 and thereby also advancing anchor cap 1110. The tipsof the tissue anchors are no longer held captive if anchor cap 1110 isadvanced sufficiently to a point past the tips of the tissue anchors. Asguide members 1104 curve away from anchor cap 1110, advancing tissueanchors 1109 causes the tips of the tissue anchors to move away from andavoid anchor cap 1110.

Articulation mechanism 1107 (e.g., articulation joints) of the tool isshown in a curved configuration or state. Articulation mechanism 1107may be curved using wires (not shown) that are carried on opposing sidesrelative to a longitudinal axis of the articulation mechanism and fixedto the distal end of the articulation mechanism 1107. Tensioning onewire causes the articulation mechanism 1107 to arc in the direction ofthe side of the articulation mechanism on which the tensioned wire iscarried in. For some situations, it is desirable to cause gaps betweenarticulation links or articulation joints to open at different rates.For example, when inserting articulation mechanism 1107 into the leftatrium, it may be preferable to cause the distal links, such asarticulation link or joint 1113 and articulation link or joint 1114, toseparate or bend prior to or more than the proximal articulation linksor joints, such as articulation link or joint 1115 and articulation linkor joint 1116. One embodiment to enable such an attribute is to insertsprings, as indicated by 1108 and 1102, with varying spring constant kbetween the links or articulation joints. To cause the distal end ofarticulation mechanism 1107 to bend first, the distal links should beforced apart by springs with a higher spring constant than the springsbetween the proximal links. Another embodiment for enabling unequalseparation of articulation links or joints is to control the shape ofthe guide members 1104 that are routed through the articulationmechanism 1107. The guide members should have a preformed bend with adecreasing radius of curvature in the area from proximal articulationlink or joint 1115 to distal articulation link or joint 1114.

FIG. 12 shows a configuration of tissue anchors and push tubes at adistal tip of a medical device system according to one illustratedembodiment. For clarity, FIG. 12 omits guide members and anchor guideframe that would typically be located at the distal tip of the medicaldevice system.

An articulation mechanism 1204 may include multiple lumens 1208 throughwhich push tubes 1202 are carried. In this particular embodiment, threelumens 1208 are employed, but other embodiments may comprise more orless. Push tubes 1202 may also include multiple lumens. In thisparticular embodiment, each push tube 1202 has a lumen 1201 in which aguide member (e.g., guide wire or rail) (not shown) may be carried and asecond lumen that carries a release member (e.g., rod or wire) (notshown) which is connected to the tissue anchors 1209. Constriction tubes1205 may be mated into or onto the distal end of the second lumen. Alltissue anchors may be connected by a flexible cable 1207. The flexiblecable 1207 may also be carried within a separate lumen within thearticulation mechanism 1204. Lumens 1203 are used to carry cables thatcontrol the curvature of the articulation mechanism 1204.

FIG. 13 shows a cross section of a heart with an anchor guide frameaccording to one illustrated embodiment positioned within a left atriumof the heart.

An anchor guide frame 1303 is shown self-located on a mitral annulus1304 within the left atrium. The tissue anchor deployment sites 1301 arepreferably located on the mitral annulus and coincident with bends inthe guide members (e.g., guide wires or rails) 1302. While FIG. 13 showsthree guide members 1302 and tissue deployment sites 1301 forsimplicity; in many cases more deployment sites and guide members aredesirable. In such cases, it is a simple matter to add additional guidemembers and anchor deployment sites to the illustrated embodiment.

An alignment fin 1305 may fit between mitral valve leaflets 1306. Themovement and anatomical structure of the mitral valve leaflets 1306exert force on alignment fin 1305 and assist in orienting the anchorguide frame 1303 correctly

FIG. 14 shows a cross section of a heart with an installed assemblycapable of constricting a mitral valve annulus according to oneillustrated embodiment.

Tissue anchors 1401, 1402, and 1403 are shown fully deployed on themitral annulus 1406. Tissue anchors 1401-1403 may be connected by aflexible cable 1405. Other mechanisms for connecting tissue anchors1401, 1402, 1403 are possible. For example, rigid members, preferablywith adjustable length (e.g., turn-buckles), may be used to connect thetissue anchors 1401-1403. Flexible cable 1405 may slide through holes onthe tissue anchors 1401, 1402, 1403.

Flexible cable 1405 may pass through a hollow spreader bar 1404. Hollowspreader bar 1404 provides support to keep tissue anchors 1401 and 1403from moving closer together when flexible cable 1405 is shortened. Suchsupport reduces undesired forces being applied to an aortic valve 1407of the heart.

Reducing a distance between pairs of the tissue anchors 1401, 1402 and1402, 1403 causes an anterior-posterior (A-P) annular dimension of themitral valve to reduce and improves leaflet coaptation. Several methodsmay be used to reduce the distance between two or more pairs of tissueanchors 1401, 1402 and 1402, 1403. A first method is to shorten thecable during the installation procedure by routing the flexible cable1405 through fastener 1408, pulling the cable manually to be as tight asdesired and crimping fastener 1408. Fastener 1408 may also beconstructed using a one way clutch so that the flexible cable 1405 canonly be pulled through in one direction, in which case crimping is notrequired. A second method of reducing tissue anchor separation (i.e.,distance between two successive tissue anchors) is to include shorteningactuator 1409 between two tissue anchors. In the case where shorteningactuator 1409 is included, flexible cable 1405 is split and attached toeither end of the shortening actuator. One embodiment of shorteningactuator 1409 contains an element that is capable of changing length asa response to a stimulus such as changes in an external magnetic fieldor heating induced by a changing magnetic field. The element capable ofchanging lengths may be made of a highly magnetostrictive alloy such asTerfenol-D or from a Shape Memory Alloy (SMA) such as specially treatedNitinol. Embodiments of such actuators are described in U.S. Ser. No.11/902,199. The element capable of changing lengths may be made of aspring under tension (e.g., in an extended configuration) encapsulatedin a retainer material that changes state in response to a stimulus(e.g., melts under low heat and solidifies at body temperature—such as athermoplastic polymer). Current induced in a loop by an externalmagnetic field may be channeled through the spring. The current may heatthe spring which will cause the polymer to soften and the spring lengthto contract to an unextended configuration. The contraction of thespring can be used to reduce the separation of the tissue anchors.Embodiments of such actuators are described in U.S. Ser. No. 11/905,771.

A closed, electrically conducting loop is required if shorteningactuator 1409 is to be responsive to heating or energy induced by achanging magnetic field. Such a loop may be achieved by using anelectrically conductive material for flexible cable 1405 and ensuring anelectrical contact between both ends of flexible cable 1405 that areconnected to shortening actuator 1409.

FIGS. 15A and 15B show a tool and fastener used to tighten and secure acable according to one illustrated embodiment.

Fastener 1507 may be used to tighten or secure cables being used toconstrict a bodily orifice. Typically prior to attachment of fastener1507, tissue anchors have been implanted or placed in the tissue, and aflexible cable has been connected to the tissue anchors. Cable end 1504and cable end 1503 are typically carried in catheter sheath 1505 androuted outside the body. Cable end 1504 and cable end 1503 may be thetwo ends of one flexible cable. The portion of the cable not shown loopsaround the orifice to be constricted and is attached to the implantedtissue anchors used to secure the cable to the orifice.

Cable end 1504 may be fed into hole 1511 and locked by ferrule 1510while fastener 1507 is still outside the body. Cable end 1503 may berouted through taper lock 1509 while fastener 1507 is still outside thebody.

Fastener 1507 may be attached to fastener positioning tube 1506. Cableend 1503 may be inserted through slot 1502 and into fastener positioningtube 1506. Fastener 1507 and fastener positioning tube 1506 may beinserted into catheter sheath 1505 and advanced until fastener 1507 isproximate an annulus of the orifice to be constricted. Cable end 1503may be pulled in a direction away from fastener 1507, causing the cableto pull through taper lock 1509 and constrict the orifice. While thecable is being tightened and secured, fastener 1507 may be held byfastener positioning tube 1506. Taper lock 1509 restricts cable end 1503from being pulled out the right side (as illustrated in FIGS. 15A, 15B)of fastener 1507. Taper lock 1509 may have teeth 1515 to grip cable end1503. Taper lock 1509 may have a longitudinal slot to enable compressionof taper lock 1509 and constriction around cable end 1503. Spring 1508may force taper lock 1509 into a conical hole 1514, causing the forcetaper lock 1509 to tighten around cable end 1503.

When the orifice has been sufficiently constricted, cable end 1503 maybe severed using cable cutting tube 1501. Cable cutting tube 1501includes a sharpened end 1516. In particular, FIG. 15A shows cablecutting tube 1501 in a retracted position. The cable cutting tube mayslide inside of fastener positioning tube 1506. FIG. 15B shows cablecutting tube 1512 in the cable cutting position, physically engaging thecable 1513. Cable cutting tube 1512 may sever cable end 1513 by forcingcable end 1513 against the end of slot 1516. The cable end may besevered in other ways, including using a hot tip to melt through thecable.

FIGS. 16A and 16B show a catheter with grooves, or side slots, and amechanism for securing cables or wires in said side slots according toone illustrated embodiment.

In particular, FIG. 16A shows catheter 1604 with cables 1601 held withinlongitudinal groove 1603 on the inner surface of the tube wall by tube1602. The longitudinal groove 1603 has a cross sectional shape thatenables tube 1602 to be held captive. FIG. 16A shows a circular groove(i.e., arcuate cross-section), but other shapes may be used. Tube 1602carries cables 1601. Tube 1602 could also carry wires or tubes. Whentube 1602 is removed by pulling it out the end, as shown in FIG. 16B bycatheter 1607, cables 1605 are free to move into the central area of thetube. Tube 1602 can be reinserted over cables 1605 to again constrainthem in groove 1603.

Although FIGS. 16A and 16B show catheter 1604 and catheter 1607 withonly one groove 1603, it is possible to have many such grooves in acatheter and to secure a plurality of wires and tubes in said grooves.One of the reasons for securing cables or wires in grooves, or sideslots, is to eliminate tangling of cables or wires during medicalprocedures.

FIG. 17 shows a mechanism for holding a tissue anchor captive accordingto one illustrated embodiment

Tissue anchor 1703 may be held captive in constriction tube 1706 of thetool by release member 1704. Constriction tube 1706 may be inserted andsecured to a distal end of one lumen of push tube 1701. Constrictiontube 1706 may be held captive in the lumen by one or more ribs 1705.

Tissue anchor 1703 may be released from constriction tube 1706 byretracting push tube 1701 and constriction tube 1706 relative to releasemember 1704. As the distal end of constriction tube 1706 clears hole1707, tip of release member 1708 will pop out of hole 1707 and tissueanchor 1703 will no longer be held captive.

Lumen 1702 of push tube 1701 may be used to slide over a guide member.

FIGS. 18A and 18B show mechanisms for restricting a tissue anchor fromrelease until anchor is fully embedded in tissue according to oneillustrated embodiment

An additional benefit is provided if the tool to implant the implantabledevice for constricting a bodily orifice does not release tissue anchorsof the implantable device until the tissue anchors are fully embedded inthe tissue. It is possible to achieve this benefit by adding anadditional latch 1806, 1810 to the tool.

In particular, FIG. 18A shows a tissue anchor 1802 prior to deployment.The tissue anchor 1802 may not be released from constriction tube 1805by retracting push tube 1803 and constriction tube 1805 relative torelease member 1804 because latch 1806 in an engaged or locked positionextends into a notch 1801. Latch 1806 is coupled to lever 1807 in thisillustrated embodiment.

FIG. 18B shows the tissue anchor 1808 fully deployed into tissue 1812.As tissue anchor 1808 was deployed into tissue 1812, the surface oftissue 1812 causes lever 1811 to bend. When lever 1811 is bent, latch1810 clears notch 1813. Once latch 1810 clears notch 1813, tissue anchor1808 may be released from constriction tube 1809.

FIGS. 19A-19D show an implant member 1900, according to one illustratedembodiment. In particular, FIGS. 19A and 19B show the implant member ina first configuration that is representative of one of a deliveryconfiguration, an unanchored configuration or an untensionedconfiguration, while FIGS. 19C and 19D show the implant member in secondconfiguration that is representative of one of an implantableconfiguration, a deployed configuration, an anchored configuration or atensioned configuration. This implant member 1900 may be particularlysuitable for use with the tissue anchors, anchoring guiding frame andtechniques of FIGS. 5C, 5D, and FIGS. 8C-8F.

The implant member 1900 may be used to reshape, reconfigure and/orreinforce an orifice in bodily tissue. For example, the implant member1900 may be used to reshape, reconfigure and/or reinforce a valve, forinstance a natural valve or an artificial valve. The valve may, forexample take the form of a mitral, tricuspid, pulmonary and/or aorticvalve of the heart. Alternatively, the valve may take the form ofanother valve in another organ of the body.

The implant member 1900 has a plurality of arcuate segments 1902 a-1902c (collectively 1902). While three segments 1902 are illustrated, theimplant member 1900 may include additional segments. The total number ofsegments 1902 may be based on the size of the valve that the implantmember 1900 will be used with. The total number of segments 1902 mayadditionally or alternatively be based on a largest lateral dimensionthat may be accommodated by a given or desired catheter (i.e., diameterof catheter lumen). For instance, employing a greater number of segments1902 means that each segment may have a smaller height 1922, while stillachieving a desired lateral dimension or height of the overall implantmember 1900 when in the implanted configuration.

The segments 1902 are physically coupled to one another, and in at leastsome configurations are articulated for movement with respect to oneanother, for example pivotal movement. The implant member 1900 includesa number of hinges 1904 a, 1904 b (collectively 1904 pivotally couplingneighboring ones of the segments 1902. Each hinge 1904 may include ahinge pin 1906 a, 1906 b (collectively 1906) received via throughholes1908 a, 1908 b (collectively 1908) in the segments 1902. The hinge pin1906 should be fixedly received in the throughhole 1908 to ensure thatthe hinge pin 1906 does not become dislodged after implantation. Thehinge pin 1906 may be swaged in the throughhole 1908, and mayadditionally or alternatively be fixed using other mechanisms. Thelocations of the hinge pins 1906 of the hinges 1904 may be offset from alongitudinal centerline (i.e., the arc that passes longitudinallythrough the geometric center between the longitudinal arcuate edges) ofthe respective one of the arcuate segments 1902. Such may avoid havingto remove material on an outside edge to allow the segments 1902 topivot. Alternatively, the hinge pins 1906 may lie along the longitudinalcenterline.

The segments 1902 include stops 1909 a-1909 d (collectively 1909)proximate the hinges 1904. The stops 1909 on neighboring ones of thesegments 1902 cooperatively interact by engaging one another to preventthe segments 1902 from being pivoted past a defined angle with respectto one another. The stops thus serve to lock the segments 1902 fromfurther articulation in one direction, from the delivery configurationto the implanted configuration. While illustrated as simplecomplimentary engagement surfaces, the stops may take other forms. Forexample, stops may take the form a detent or other lock structure. Stops1909 may lock the segments 1902 from movement in two, opposeddirections. Stops 1909 may also provide torsional stiffness to thehinges 1904.

In some example embodiments, a portion of an implant member having avariable bending stiffness in at least one dimensional plane isemployed. In this illustrated embodiment, implant member 1900 isconfigured to be bendable between a first configuration in which implantmember 1900 has an elongated shape and a second configuration in whichimplant member 1900 has an arcuate shape. Stops 1909 allow portions ofthe implant member 1900 coupled by hinges 1904 to have a variablebending stiffness in at least one dimensional plane. Hinges 1904 allowimplant member 1900 to bend via the articulation of segments 1902 in aplane when implant member 1900 is in its first configuration. Stops 1909restrain further articulation between segments 1902 when implant member1900 is in the second configuration and any further bending is dependenton any additional flexing of segments 1902. In this regard, the implantmember 1900 has a reduced bending stiffness in the at least onedimensional plane when the implant member 1900 is in the firstconfiguration and an increased bending stiffness in the one dimensionalplane when the implant member 1900 is in the second configuration.Variable bending stiffness characteristics can be achieved in other waysby other example embodiments. The implant member 1900 includes a numberof guide line receivers 1910 a-1910 c (collectively 1910). The guideline receivers 1910 may be formed as holes or apertures and are sized toreceive a guide line such as a guide wire (not shown in FIGS. 19A-19D)to allow the implant member 1900 to ride on or otherwise be guided oradvanced along the guide line. The guide line may, for example, take theform of the guide wire of FIGS. 5C, 5D and FIGS. 8C-8F. In variousembodiments, the guide line receivers 1910 allow implant member 1900 toride on, or otherwise be guided or advanced along a guide line that isreceived or coupled to a tissue anchor that is embedded into tissue. Theguide line receivers 1910 a, 1910 c are located proximate a first end1912 a, a second end 1912 b, respectively. The guide line receiver 1910b is between the first and second ends 1912 a, 1912 b. In particular,each of the segments 1902 may have one of the guide line receivers 1910.While illustrated as being approximately midway between the first andsecond ends 1912 a, 1912 b, the guide line receiver 1910 b between thefirst and second ends 1912 a, 1912 b may be offset to one side or theother of a center line (perpendicular bisector 1924) of the implantmember 1900, along a longitudinal axis thereof. The implant member 1900may include additional guide line receivers (not shown). For instance,all or some of one or more additional segments (not shown) may haveguide line receivers. Additionally, or alternatively, one segment 1902may have more than one guide line receiver 1910. One or more of thesegments 1902 may include relief 1911 (only one called out in FIG. 19B)proximate the guide line receiver 1910. The relief 1911 may accommodatea guide line such as a wire or suture.

As illustrated in FIGS. 19A and 19B, the segments 1902 of the implantmember 1900 may be moved with respect to one another, into a firstconfiguration, which in this illustrated embodiment is representative ofa delivery configuration or unanchored configuration. In the delivery orunanchored configuration, the implant member 1900 is sized anddimensioned to be deliverable via a catheter. In the deliveryconfiguration, the implant member 1900 may have an elongated, scallop orserpentine profile, as best illustrated in FIG. 19B. A maximumlongitudinal dimension in the delivery or unanchored configuration isrelatively long as compared to the maximum longitudinal dimension in theimplanted or anchored configuration. Thus, a maximum lateral dimensionof the implant member 1900 (i.e., maximum dimension measuredperpendicularly to a longitudinal axis extending between the first andsecond ends 1912 a, 1912 b), is minimized. The maximum lateral dimensionin the delivery or unanchored configurations is relatively short orsmall as compared to the maximum lateral dimension in a secondconfiguration, which in this illustrated embodiment is representative ofan implantable or deployed or anchored configuration. As illustrated inFIG. 19B, the maximum lateral dimension may, for example, beapproximately equal to a height 1922 of the arch formed by the one ofthe arcuate segments 1902 (i.e., 1902 b in this illustrated embodiment),as measured by a perpendicular bisector 1924 that extends from a chordline 1926 passing tangent to portions of an inner surface 1928 (calledout twice in FIG. 19B) of one or more of the arcuate segments 1902, towhere the perpendicular bisector 1924 intersects an outer surface 1930of the arcuate segment 1902 when the plurality of arcuate segments arepositioned in the delivery or unanchored configuration. Thus, theimplant member 1900 may be accommodated by a catheter. Catheters aretypically long, but which have relatively narrow diameters. Thus,catheters have relatively unlimited longitudinal capacity as compared tolateral or radial capacity.

As illustrated in FIGS. 19C and 19D, the segments 1902 of the implantmember 1900 may be moved with respect to one another into the secondconfiguration representative of an implantable or deployed or anchoredconfiguration. In the second configuration, the implant member 1902 hasan arcuate or annular shape or profile. The arcuate or annular shape issized and dimensioned to encompass at least part of an orifice. Forexample, the arcuate or annular shape may be sized and dimensioned tooverlie part of an annulus of a mitral valve of a heart. In the secondconfiguration, the dimensions of the implant member 1902 are too largeto be accommodated by a typical catheter. In particular, a lateraldimension or height of the implant member is too large to be received bya lumen of the catheter.

As described in detail below, forces or tension may be applied to theimplant member 1900 at the guide line receivers 1910, for instance viaembedded tissue anchors and/or wires and/or sutures. Such may tensionthe implant member 1900 into the second configuration (FIGS. 19C and19D), while the stops 1909 prevent the segments 1902 of implant member1900 from articulating past the implanted configuration. Such results inthe implant member 1900 having a rigid structure in the secondconfiguration.

FIG. 20A-20D show an implant member 2000, according to one illustratedembodiment. In particular, FIGS. 20A and 20B show the implant member2000 in a first configuration representative of a delivery configurationor an unanchored configuration, while FIGS. 20C and 20D show the implantmember 2000 in a second configuration representative of a deployedconfiguration or an implantable configuration or an anchoredconfiguration. This implant member 2000 may be particularly suitable foruse with the tissue anchors, anchoring guiding frame and techniques ofFIGS. 5C, 5D, and FIGS. 8C-8F, by way of non-limiting example.

The implant member 2000 may be used to reshape, reconfigure and/orreinforce an orifice in bodily tissue. For example, the implant member2000 may be used to reshape, reconfigure and/or reinforce a valve, forinstance a natural valve or an artificial valve. The valve may, forexample take the form of a mitral, tricuspid, pulmonary and/or aorticvalve of the heart. Alternatively, the valve may take the form ofanother valve in another organ of the body.

The implant member 2000 has a plurality of arcuate segments 2002 a-2002h (collectively 2002). While eight segments 2002 are illustrated, theimplant member 2000 may include fewer or greater number of segments. Thetotal number of segments 2002 may be based on the size of the valve thatthe implant member 2000 will be used with. The total number of segments2002 may additionally or alternatively be based on a largest lateraldimension that may be accommodated by a given or desired catheter (i.e.,diameter of catheter lumen). For instance, employing a greater number ofsegments 2002 means that the implant member 2000 may have a smallerheight in the first configuration, while still achieving a desiredlateral dimension or height of the overall implant member 2000 when inthe second configuration.

The segments 2002 are physically coupled to one another, and in at leastsome configurations are articulated for movement with respect to oneanother, for example pivotal movement. The implant member 2000 includesa number of flexure joints 2004 a-2004 g (collectively 2004) pivotallycoupling neighboring ones of the segments 2002. Each flexure joint 2004may be defined by a recess 2006 (only one called out in FIG. 20C)defined in the implant member 2000. Thus, in contrast to the implantmember 1900 (FIGS. 19A-19D), the implant member 2000 may be a unitarystructure formed from a single piece of material. The recesses 2006 areillustrated as being on an inner radius, diameter or surface 2019 of theimplant member 2000. Alternatively, recesses may be formed on an outerradius, diameter or outer peripheral surface 2020 of the implant member,diametrically opposed to the recesses 2006 illustrated in FIGS. 20A-20D.

The recesses 2006 may be defined or formed via machining operations, forinstance drilling, milling, laser cutting, water jetting, etc. Inparticular the recesses 2006 may have an entrance 2008 (only one calledout in FIG. 20C) at an inner peripheral surface 2019 of the implantmember 2000, and may have an enlarged portion 2009 (only one called outin FIG. 20C) spaced inwardly of the entrance 2008. The recesses 2006 mayhave rounded corners which may alleviate stress and/or possible crackformation. Such may also prevent snagging or tearing of bodily tissue.

The implant member 2000 may employ the resiliency of the material fromwhich the implant member 2000 is formed to limit the bending or travelof the segments 2002. Alternatively, the implant member 2000 may includestops proximate the flexure joints 2004. The stops on neighboring onesof the segment 2002 would cooperatively interact by engaging one anotherto prevent the segments 2002 from being pivoted past a defined anglewith respect to one another. Accordingly, in various exampleembodiments, a portion of implant member 2000 has a variable stiffnessin at least one dimensional plane. In a manner similar to otherdescribed embodiments, the use of stops can allow implant member 2000 tohave a reduced bending stiffness when implant member 2000 is in itsfirst configuration and an increased bending stiffness when implantmember 2000 is in its second configuration. In this example embodiment,a portion of implant member 2000 has a substantially equal bendingstiffness in each of a plurality of directions in at least onedimensional plane when implant member 2000 is in its first configurationwhile the portion of implant member 2000 has a substantially unequalbending stiffness in each of the plurality of directions in the at leastone dimensional plane when implant member 2000 is in its secondconfiguration. In this example embodiment, the stops provide the unequalbending stiffness in each of the plurality of directions in the at leastone dimensional plane when implant member 2000 is in its secondconfiguration.

The implant member 2000 includes a number of guide line receivers 2010a-2000 c (collectively 2010). The guide line receivers 2010 are formedas holes or apertures and are sized to receive a guide line or wire (notshown in FIGS. 20A-20D) to allow the implant member 2000 to ride on orotherwise be guided or advanced along the guide line. The guide linereceivers 2010 are located proximate a first end 2012 a, a second end2012 b and between 2012 c the first and second ends 2012 a, 2012 b. Inparticular, only some of the segments 2002 may have one of the guideline receivers 2010. While illustrated as being approximately midwaybetween the first and second ends 2012 a, 2012 b, the guide linereceiver 2010 b between the first and second ends 2012 a, 2012 b may beoffset to one side or the other of a center line (perpendicular bisector2024) of the implant member 2000, along a longitudinal axis thereof. Theimplant member 2000 may include additional guide line receivers (notshown). For instance, all or some of one or more additional segments(not shown) may have guide line receivers. Additionally, oralternatively, one segment 2002 may have more than one guide receiver2010. Similar to previously described embodiments, each of one or moreof the segments 2002 may include a relief (not shown) proximate theguide receiver 2010. Each of these reliefs may accommodate a guide linesuch as a guide wire or suture.

As illustrated in FIGS. 20A and 20B, the segments 2002 of the implantmember 2000 may be moved with respect to one another, into a firstconfiguration representative of a delivery or unanchored configuration.In the first configuration, the implant member 2000 is sized anddimensioned to be deliverable via a catheter. In the firstconfiguration, the implant member 2000 may have an elongated crenulatedprofile, as best illustrated in FIG. 20B. A maximum longitudinaldimension in the first configuration is relatively long as compared tothe maximum longitudinal dimension in a second configuration that isrepresentative of an implantable, deployed or anchored configuration.Thus, a maximum lateral dimension of the implant member 2000 (i.e.,maximum dimension measured perpendicularly to a longitudinal axisextending between the first and second ends 2012 a, 2012 b), is reduced.The maximum lateral dimension in the first configuration is relativelyshort or small as compared to the maximum lateral dimension in thesecond configuration. As illustrated in FIG. 20B, the maximum lateraldimension may, for example, be approximately equal to a height 2022 ofthe arch formed by the implant member 2000, as measured by aperpendicular bisector 2024 that extends from a chord line 2026 passingtangent to portions 2028 of an inner surface located at the first andsecond ends 2012 a, 2012 b, to where the perpendicular bisector 2024intersects an outer surface 2020 of the implant member 2000. Thus, theimplant member 2000 may be accommodated by a catheter, which cathetersare typically long but which have relatively narrow diameters.

As illustrated in FIGS. 20C and 20D, the segments 2002 of the implantmember 2000 may be moved with respect to one another into a secondconfiguration representative of an implantable, deployed or anchoredconfiguration. In the second configuration, the implant member 2000 hasan arcuate, annular or C-shape or profile. The arcuate, annular orC-shape is sized and dimension to encompass at least part of an orifice.In the second configuration, the dimensions of the implant member 2000are too large to be accommodated by a typical catheter sheath. Inparticular, a lateral dimension or height of the implant member is toolarge to be received by a lumen of the catheter.

As described in detail below, forces or tension may be applied to theimplant member 2000 at the guide line receivers 2010, for instance viatissue anchors and/or guide lines, guide wires and/or sutures. Such maytension the implant member 2000 into the second configuration (FIGS. 20Cand 20D).

FIG. 20E shows an implant cross member 2050, according to oneillustrated embodiment. The implant cross member 2050 may have two ormore guide line receivers 2052, to receive guide lines such as guidewires (not shown in FIG. 20E). The guide line receivers 2052 may beproximate opposite ends of the implant cross member 2050. Thus, theimplant cross member 2050 may ride or otherwise advance along the guidelines or guide wires toward tissue anchors embedded in tissue. Theimplant cross member 2050 can be anchored across the ends of arms of animplant member such as implant member 1900 (FIGS. 19A-19D), or implantmember 2000 (FIGS. 20A-20D) to form a generally D-shape profile with theimplant member. The implant cross member 2050 may take the form of anelongated generally rigid structure or an elongated cable or wire, whichis generally rigid once anchored. Such may result in a more rigidstructure than the structures having generally C-shaped profiles. Theimplant cross member 2050 may optionally include couplers (not shown) tocouple to complimentary couplers on the implant member 1900, 2000.

In contrast to other valve reformation structures, at least some of theimplant members described herein such as implant members 1900 (FIGS.19A-19D), 2000 (FIGS. 20A-20D), do not need to have a cable passingthrough all of the segments as the sole means of coupling the varioussegments together. In contrast to other valve reformation structures,implant members such as implant members 1900 (FIGS. 19A-19D), 2000(FIGS. 20A-20D) do not need to be positioned on tissue surrounding avalve, and then secured to the surrounding tissue and finally cinchedtogether to alter the shape of the valve. Rather, in variousembodiments, implant members such as implant members 1900, 2000 aresecured to tissue anchors (i.e., FIG. 3, FIGS. 4A-4B, FIGS. 5A-5D, FIGS.6A-6B, FIGS. 7A-7C and FIGS. 8A-8D, by way of non-limiting example) thathave been previously embedded or previously anchored into the tissuesurrounding the orifice proximate at least three locations. It is notedthat in some example embodiments, each tissue anchor is individuallyembedded into tissue, while in other example embodiments, the tissueanchors are embedded into the tissue as a group. In the previouslydescribed example embodiments, guide lines that are received or coupledto the embedded tissue are received by guide line receivers 1910, 2010provided by respective ones of implant members 1900, 2000 to provide aphysical path for implant member 1900, 2000 to travel to the embeddedtissue anchors. As the implant member 1900, 2000 travels towards theembedded tissue anchors, each of the guidelines is configured to receivea tensile force sufficient to apply force to bend or position implantmember 1900, 2000 into its deployed or implantable configuration (i.e.,the second configuration). In various example embodiments, at least someof the guide lines impart force to the implant member 1900, 2000 as itmoves along the physical path to the embedded tissue anchors.

In various example embodiments, the implant member 1900, 2000 isappropriately sized and dimensioned so that the tensile force applied toeach of the guide lines is sufficient to cause a portion of the tissueinto which a respective tissue anchor is embedded to move towards theimplant member 1900, 2000 as the implant member 1900, 2000 is positionedinto its second configuration. In various example embodiments, thesegments 1902, 2002 of respective ones of the implant member 1900, 2000in the second configuration enclose at least partially, an area that issmaller than an area of an annulus of an orifice (e.g., a mitral valve)prior to a physical coupling between the implant member 1900, 2000 andthe tissue. In various example embodiments, a circumference defined by acircle passing through at least three locations of the guide linereceivers 1910, 2010 on a respective one of the implant member 1900,2000 in the second configuration is smaller than a circumference of anannulus of the tissue orifice or valve prior to a physical couplingbetween the implant member 1900, 2000 and the embedded tissue anchors.In various example embodiments, a circumference defined by a circlepassing through at least three locations of the guide line receivers1910, 2010 on a respective one of the implant member 1900, 2000 in thesecond configuration is smaller than a circumference defined by a circlepassing through at least three locations of the embedded tissue anchorsprior to a physical coupling between the implant member 1900, 2000 andthe embedded tissue anchors.

It is noted that the force applied by the anchoring maintains theimplant member 1900, 2000 under tension in the desired implantableconfiguration when the implant member 1900, 2000 is finally secured tothe tissue. Advantageously, implant member 1900, 2000 is positionablebetween a first configuration in which respective ones of segments 1902,2002 are articulable with respect to one another such that the implantmember 1900, 2000 is manipulable to a size and dimension to bedeliverable via a catheter and a second configuration in which thesegments 1902, 2002 form a structure sufficiently rigid to affect ashape of a tissue valve or orifice in a desired manner. In this regard,each of the implant member 1900, 2000 has a reduced bending stiffness inat least one dimensional plane in the first configuration to allow it tobe deliverable via a catheter and an increased bending stiffness in theat least one dimensional plane sufficient to form a structuresufficiently rigid to affect the shape of a tissue valve or orifice in adesired manner. In various example embodiments, the guide lines andembedded tissue anchors apply tension to the implant member 1900, 2000in the second configuration that is sufficient to restrain disengagementof a respective one of a coupled segment 1902, 2002 with a stopassociated with the coupled segment. In various example embodiments, theguide lines and embedded tissue anchors apply tension to the implantmember 1900, 2000 in the second configuration that is sufficient to flexat least one of a respective segment 1902, 2002 while the segment isengages with an associated stop. The applied tension provided to theimplanted implant member 1900 in these example embodiments may reducewear on the components of the associated hinges 1904 as the implantedimplant member 1900 is subsequently repeatedly stressed by therecipient's cardiac cycle which can be in the millions of cycles. Theapplied tension provided to the implanted implant member 2000 in theseexample embodiments may reduce fatigue effects as the implanted implantmember 2000 is subsequently repeatedly stressed by the recipient'scardiac cycle. While some of the described embodiments may employ acable between end segments of the articulated structure as an implantcross member, adjacent pairs of the segments are coupled together viarespective hinges rather than a cable.

The implant member 1900, 2000 may, for example, have a length (e.g.,measured from guide receiver 1910 a to 1910 b) of from approximately 24mm to approximately 38 mm, inclusive. Implant members 1900, 2000 may beavailable in a variety of lengths, for instance in 2 mm increments, toaccommodate various valve sizes. The implant members 1900, 2000 may havea thickness of approximate 2 mm, although other thickness may beemployed. The width of the segments of the implant members 1900, 2000may, for example, be approximately 2 mm, although other widths may beemployed. The implant members 1900, 2000 may, for example, have a heightthat is between approximately 30% and approximately 50% of thelongitudinal length. The implant members 1900, 2000 may, for example,have a height that is between approximately 60% and approximately 65% ofthe longitudinal length, for example 63% of the longitudinal length.Such ratio may provide sufficient force to approximate theanterior-posterior dimension of a mitral valve. In some embodiments, theimplant member 1900, 2000 may, for example, have an arcuate, annular orC-shape. The implant member 1900, 2000 may be sized and dimension toencompass over a third or over half (i.e., substantially) of theorifice. For example, the arcuate, annular or C-shape may be sized anddimensioned to overlie part of an annulus of a mitral valve of a heart,surrounding approximately half the mitral value. Such may advantageouslyallow the anterior-posterior dimension of the mitral valve to bemodified (e.g., reduced). Implant members such as implant members 1900,2000 may be formed from or comprise a variety of materials. Thematerials may include a biocompatible material which does not react inor with the tissue or bodily fluids. For example, the implant members1900, 2000 and/or implant cross member 2050 may be formed of metals suchas Nitinol, stainless steel, platinum, iridium, titanium, or polymerssuch as polytetrafluoroethylene (PTFE) or silicone. Also for example,the implant members 1900, 2000 and/or implant cross member 2050 may beformed tissue (e.g., allograft, autograft).

The implant members 1900, 2000 and/or implant cross member 2050 may havea textured exterior. Alternatively, implant members 1900, 2000 and/orimplant cross member 2050 may take the form of a tissue scaffold, forinstance a scaffold constructed using 3-D printing techniques. Suchtextured surface or scaffold may encourage biological overgrowth. Theimplant members 1900, 2000 and/or implant cross member 2050 may carryone or more functional coatings or layers. Such may either encourage orinhibit formation of scarring, may deliver (e.g., elute) a therapeuticagent to the organ or blood. Such may include gold, heparin, carbonnanocomposite, silicon carbide, titanium-nitride-oxide,phosphorylcholine, etc.

FIGS. 21A and 21B show a fastener 2100 that fastens to a guide line suchas a guide wire 2102, according to one illustrated embodiment.

The fastener 2100 has a cavity 2104 which provides a passage through thefastener 2100 for the guide line (e.g., Nitinol wire). The cavity 2104may include openings in two opposed surfaces of the fastener 2100 toprovide a passage for the guide line or guide wire 2102. The cavity 2104may have a sloped wall 2106. The cavity 2104 may contain one or morecams or clutches 2108, for instance a spring 2108 a and ball 2108 b. Theball 2108 b is biased toward the sloped wall 2106 by the spring 2108 a.While illustrated as a coil spring, other types of springs may beemployed. The cam or clutch 2108 may include a seat 2108 c which has astem to retain the spring 2108 a and an aperture or concavity to retainthe ball 2108 b. The ball 2108 b frictionally engages the guide line orguide wire 2102 against the sloped wall 2106 in response to movement ofthe fastener 2100 along the guide line 2102 toward an embedded tissueanchor (not shown in FIG. 21A or 21B). The fastener 2100 may be aunidirectional or a one way fastener or clutch, allowing the fastener2100 to ride or move along the guide line or guide wire 2102 in onedirection, but resisting movement in the opposite direction. Such may beemployed to secure the fastener 2100 against the implant member (notshown in FIG. 21A or 21B) percutaneously, to secure the implant memberto the tissue anchors which are embedded in the tissue. Other cams orclutches may be employed. For instance, an arcuate section pivotallymounted and biased, for example by a leaf spring, to engage the guideline or guide wire, may be used. The fastener 2100 may be comprised of abiocompatible material, for example a metal that does not react withbodily tissues or fluids. The fastener 2100 may include a tubularhousing, which may be cylindrical. An end cap may be secured to thehousing, for example via spot welding. The fastener 2100 may, forexample, have a total volume of 8 cubic millimeters. The ball 2108 bmay, for example, have a diameter of approximately 0.5 mm.

FIGS. 22A and 22B show a fastener 2200 that fastens a guide line 2202 toa tissue anchor 2204, according to another illustrated embodiment.

The fastener 2200 physically interacts with a fastening portion 2206 ofthe tissue anchor 2204. In particular, the fastener 2200 has a slopedouter surface or swaging surface 2208 that is received in a cavity 2210of the fastening portion 2206 of the tissue anchor 2204. Engagement ofthe inner wall forming the cavity 2210 plastically deforms the fastener2200, increasing the frictional force applied to the guide line 2202.Such can secure the fastener to the tissue anchor 2204, secure the guideline 2202 to the fastener 2200. The fastener 2200 is a bidirectionalfastener, resisting movement of the guide line 2202 in either directiononce swaged. Such may be employed to secure the fastener against theimplant member in its second configuration (not shown in FIG. 22A or22B) to secure the implant member to the tissue anchors embedded in thetissue. While illustrated with the fastener 2200 having a sloped surface2208, in some embodiments, the inside wall forming the cavity 2210 maybe sloped to achieve a similar result. The fastener 2200 may include aperipheral flange 2212 to form a head. The size of the peripheral flange2212 may be larger than the openings of the implant member that receivethe guide lines 2202. The fastener 2200 may be comprised of abiocompatible material, for example a metal that does not react withbodily tissues or fluids.

Fasteners other than fasteners 2100, 2200 generally described above maybe employed in various example embodiments. While illustrated asseparate from the implant member, the fasteners may be incorporated intothe implant member. For example, the fasteners 2100, 2200 may be securedto the implant member. For instance, the fasteners 2100, 2200 may besecured in apertures or recesses of the implant member, for example viapress fit, swaging, and/or adhesives, to become an integral part of theimplant member. Alternatively, the fasteners 2100, 2200 may be formed asa unitary, single piece portion of the implant member. For instance, asillustrated in FIG. 22C, a fastener may take the form of a resilientmember, such as a tab or pawl 2250, that extends into the guide linereceiver 2252 of an implant member 2254, and which allows the guide lineto easily advance in one direction but which resists retreat of theguide line in the opposite direction. In each of these examples, apassage through the fastener 2100, 2200, 2250 may serve as the guideline receiver.

FIGS. 24A-24H show an implant member 2400, according to one illustratedembodiment. In particular, FIG. 24A shows the implant member 2400 in afirst configuration that is representative of one of a deliveryconfiguration, an unanchored configuration or an untensionedconfiguration, while FIG. 24B show the implant member 2400 in a secondconfiguration that is representative of one of an implantableconfiguration, a deployed configuration, an anchored configuration or atensioned configuration.

The implant member 2400 is similar to previously described implantmember 1900 and may be used to reshape, reconfigure and/or reinforce anorifice in bodily tissue. For example, the implant member 2400 may beused to reshape, reconfigure and/or reinforce a valve, for instance anatural valve or an artificial valve. The valve may, for example takethe form of a mitral, tricuspid, pulmonary and/or aortic valve of theheart. Alternatively, the valve may take the form of another valve inanother organ of the body.

The implant member 2400 has a plurality of arcuate segments 2402 a-2402c (collectively 2402). While three segments 2402 are illustrated, theimplant member 2400 may include additional segments. The total number ofsegments 2402 may be based on the size of the valve with which theimplant member 2400 will be used. The total number of segments 2402 mayadditionally or alternatively be based on a largest lateral dimensionthat may be accommodated by a given or desired catheter (i.e., diameterof catheter lumen). For instance, in manner similar to that describedfor implant member 1900, employing a greater number of segments 2402means that each segment may have a smaller height, while still achievinga desired lateral dimension or height of the overall implant member 2400when in the second configuration.

The segments 2402 are physically coupled to one another, and in at leastsome configurations are articulated for movement with respect to oneanother, for example pivotal movement. The implant member 2400 includesa number of hinges 2404 a, 2404 b (collectively 2404) pivotally couplingneighboring ones of the segments 2402. Each hinge 2404 may include ahinge pin 2406 a, 2406 b (collectively 2406) received via throughholes2408 a, 2408 b (collectively 2408) in the segments 2402. Each hinge pin2406 should be fixedly received in the throughhole 2408 to ensure thatthe hinge pin 2406 does not become dislodged after implantation. Thehinge pin 2406 may be swaged in the throughhole 2408, and mayadditionally or alternatively be fixed using other mechanisms. Thelocations of the hinge pins 2406 of the hinges 2404 may be offset from alongitudinal centerline (i.e., the arc that passes longitudinallythrough the geometric center between the longitudinal arcuate edges) ofthe respective one of the arcuate segments 2402. Alternatively, thehinge pins 2406 may lie along the longitudinal centerline.

The segments 2402 include stops 2409 a-2409 d (collectively 2409)proximate the hinges 2404. The stops 2409 on neighboring ones of thesegments 2402 cooperatively interact by engaging one another to preventthe segments 2402 from being pivoted past a defined angle with respectto one another. The stops 2409 thus serve to restrain the segments 2402from further articulation in one direction. While illustrated as simplecomplimentary engagement surfaces, the stops may take other forms. Forexample, stops may take the form of a detent or other lock structure.Stops 2409 may lock the segments 2402 from moving along each of twoopposing directions when the implant member is in the secondconfiguration. Stops 2409 may also provide torsional stiffness to thehinges 1904. Stops 2409 may also impart a greater bending stiffness to aportion of the implant member 2400 in its second configuration than ithas in its first configuration.

As illustrated in FIGS. 24A and 24B, the segments 2402 of the implantmember 2400 may be moved with respect to one another into a firstconfiguration, which in this illustrated embodiment is representative ofa delivery configuration or unanchored configuration or untensionedconfiguration. In the first configuration, the implant member 2400 issized and dimensioned to be deliverable via a catheter. In the firstconfiguration, the implant member 2400 may have an elongated, scalloped,crenulated or serpentine profile, as best illustrated in FIG. 24A. Amaximum longitudinal dimension in the first configuration is relativelylong as compared to the maximum longitudinal dimension in the secondconfiguration. As illustrated in FIGS. 24A and 24B, the segments 2402 ofthe implant member 2400 may be moved with respect to one another intothe second configuration representative of an implantable or deployed oranchored or tensioned configuration. In the second configuration, theimplant member 2400 has an arcuate shape or profile. The arcuate shapeis sized and dimensioned to encompass at least part of an orifice. Forexample, the arcuate shape may be sized and dimensioned to overlie partof an annulus of a mitral valve of a heart. In the second configuration,the dimensions of the implant member 2400 are too large to beaccommodated by a typical catheter sheath. In particular, a lateraldimension or height of the implant member 2400 is too large to bereceived by a lumen of the catheter sheath. Advantageously, thearticulated segments 2402 of implant member 2400 allow implant member2400 to be delivered percutaneously in a first configuration whileassuming a structure in a second configuration that is sufficientlyrigid to affect a shape of the tissue orifice in a desired manner. Inthis example embodiment, implant member 2400 is shown coupled with eachhelical tissue anchors 2418 a, 2418 b and 2418 c (collectively tissueanchors 2418) which have been previously embedded into tissue (notshown).

In a manner similar to other described embodiments, forces or tensionmay be applied to the implant member 2400 at the guide line receivers2410 (one called out in FIG. 24A), for instance via embedded helicaltissue anchors and/or wires and/or sutures (not shown in FIGS. 24A and24B). Such may tension the implant member 2400 into the secondconfiguration (FIG. 24B), while the stops 2409 prevent the segments 2402of implant member 2400 from articulating past the second configuration.Such results in implant member 2400 having a rigid structure in thesecond configuration.

In this illustrated embodiment, implant member 2400 has a plurality oftissue anchor receivers 2412 (two called out in FIG. 24A), each of thetissue anchor receivers 2412 configured to receive or mate with arespective one of the embedded helical tissue anchors 2418 when implantmember is positioned in the second configuration. In this exampleembodiment, each of the guide line receivers 2410 is co-axially alignedwith a respective one of the tissue anchor receivers, although otheralignments may be employed in other example embodiments. As implantmember 2400 travels along the guide lines extending from the embeddedhelical tissue anchors 2418, segments 2402 articulate about respectivehinges 2404 to position the implant member in the second configuration.Tensile forces on the guide lines draw portions of the tissue into whichthe helical tissue anchors 2418 are embedded towards implant member 2400as implant member 2400 transitions into the second configuration.Tensile forces on the guide lines move portions of the tissue into whichrespective ones of the helical tissue anchors 2418 are embedded intolocations where each of the embedded helical tissue anchors 2418 iscoupled with a respective one of the tissue anchor receivers 2412 whenthe implant member 2400 is in the second configuration. In thisillustrated embodiment, various portions of the tissue are moved todesired locations and are maintained in these locations by the couplingof implant member 2400 to the embedded helical tissue anchors 2418 viatissue anchor receivers 2412. In this illustrated embodiment, thecoupled embedded helical tissue anchors 2418 may cause portions of someof the segments 2402 to flex against associated stops 2408. In thisillustrated embodiment, the coupled embedded helical tissue anchors 2418tension implant member 2400 in the second configuration. The tension inthe coupled implant member 2400 in the second configuration may besufficient to reduce a pivoting movement of at least some of thesegments 2402 about their associated hinges 2404 during the recipientssubsequent cardiac cycle.

The locations of the embedded tissue anchors 2418 and the locations oftheir respective tissue anchor receivers 2412 can be configured to altera shape of a tissue valve or orifice in a desired manner. For example,FIG. 24C shows each of a first helical tissue anchor 2418 a, a secondhelical tissue anchor 2418 b and a third helical tissue anchor 2418 c(collectively helical tissue anchors 2418) embedded into a respectivelocation about a periphery of an orifice in a tissue 2430. In thisexample embodiment, a location of the embedded third tissue anchor 2418c is laterally offset by a first distance 2244 from a first axis 2440(i.e., shown in broken lines) that extends between a location of theembedded first helical tissue anchor 2418 a and a location of theembedded second helical tissue anchor 2418 b. In this exampleembodiment, helical tissue anchors 2418 are embedded into tissue 2430prior to a coupling with implant member 2400. In this exampleembodiment, the helical tissue anchors 2418 are embedded into tissue2430 that forms part of a heart. Specifically, the helical tissueanchors 2418 are embedded about a mitral annulus 2434 within a leftatrium. In this example embodiment, the location of each of the embeddedhelical tissue anchors 2418 is proximate to mitral annulus 2434. In thisexample embodiment, the location of each of the embedded helical tissueanchors 2418 is proximate to a longitudinal axis of the helical tissueanchor 2418. It is understood that the locations of the embedded helicaltissue anchors 2418 can be specified relative to other datums in otherexample embodiments. In some example embodiments, each of the helicaltissue anchors 2418 is transported sequentially through a catheter totheir respective implantation locations while in other exampleembodiments, two or more of the helical tissue anchors 2418 aretransported as a group through a catheter to their respectiveimplantation locations. In some example embodiments, each helical tissueanchor 2418 is implanted sequentially while in other exampleembodiments, two or more of the helical tissue anchors 2418 areimplanted at substantially the same time or concurrently.

FIG. 24D shows implant member 2400 coupled with the helical tissueanchors 2418 after they have been embedded into tissue 2430. Implantmember 2400 is reconfigurable between the first configuration and thesecond configuration and is selected to include at least a first tissueanchor receiver 2412 a corresponding to the first helical tissue anchor2418 a, a second tissue anchor receiver 2412 b corresponding to thesecond helical tissue anchor 2418 b, and a third tissue anchor receiver2412 c corresponding to the third helical tissue anchor 2418 c. Firsttissue anchor receiver 2412 a, second tissue anchor receiver 2412 b andthird tissue anchor receiver 2412 c are collectively referred to astissue anchor receivers 2412. As shown in FIG. 24D, implant member 2400can be selected such that a location of the third tissue anchor receiver2412 c on the implant member 2400 in the second configuration islaterally offset by a second distance 2454 from a second axis 2450(i.e., shown in broken lines) that extends between a location of thefirst tissue anchor receiver 2412 a on the implant member 2400 and alocation of the second tissue anchor receiver 2412 b on the implantmember 2400 such that the second distance 2454 is smaller than the firstdistance 2444. In this example embodiment, the location of each tissueanchor receiver 2412 is proximate to a longitudinal axis of the tissueanchor receiver 2412. It is understood that the locations of the tissueanchor receivers 2412 can be specified relative to other datums in otherexample embodiments.

As shown in FIG. 24D, a coupling between the tissue anchor receivers2418 and the embedded helical tissue anchors 2418 will affect a shape ofthe mitral annulus 2434 which can be used to reposition mitral valveleaflets 2436 relative to one another in a desired way. A couplingbetween the tissue anchor receivers 2412 and the embedded helical tissueanchors 2418 will cause a portion of the tissue 2430 into which thethird helical tissue anchor 2412 c is embedded to move relative toanother portion of the tissue 2430 in a desired way. Other portions ofthe tissue 2430 can be moved in a similar fashion based at least on theselection of an appropriately sized and dimensioned implant member 2400.

The relationship between the locations of the embedded helical tissueanchors 2418 and the locations of the tissue anchor receivers 2412employed to alter a shape of mitral annulus 2434 can be illustrated inother ways. FIG. 24C shows that a circle 2460 (i.e., shown in brokenline) can be dimensioned and sized to pass through the locations of theembedded helical tissue anchors 2418. In this example embodiment, acircumference of circle 2460 is greater than a circumference orperimeter of mitral annulus 2434. FIG. 24D shows that a circle 2470(i.e., shown in broken line) can be dimensioned and sized to passthrough the locations of the tissue anchor receivers 2412 when implantmember 2440 is coupled with the embedded tissue anchors 2418. In thisexample embodiment, circle 2460 has a circumference that is greater thana circumference of circle 2470.

FIGS. 24E and 24F respectively show a portion of a segment 2402 ofimplant member 2400 before and after a coupling with an embedded helicaltissue anchor 2418. Tissue into which helical tissue anchor 2418 isembedded is not shown for clarity. In this illustrated embodiment, aguide line 2416 extends from embedded helical tissue anchor 2418 throughthe tissue anchor receiver 2412 and guide line receiver 2410 of segment2402. Helical tissue anchor 2418 includes seat 2426 that is configuredto mate or engage with tissue anchor receiver 2412. In this illustratedembodiment, seat 2426 and tissue anchor receiver 2412 include matingtapered surfaces. Seat 2426 and helical tissue anchor may be provided asa unitary structure. Alternatively, seat 2426 may be secured to helicaltissue anchor 2418 by variety of methods including, adhesives, crimping,and heat fitting, by way of non-limiting example. In this illustratedembodiment, fastener 2420 is provided via guide line 2416 to securesegment 2402 to embedded helical tissue anchor 2418. Unlike otherfasteners employed in other described embodiments that secure an implantmember to the tissue by coupling with a guide line (e.g., fasteners2100, 2200), fastener 2420 couples directly with the embedded helicaltissue anchor 2418 itself as shown in FIG. 24F. In this illustratedembodiment, fastener 2420 includes snap-ring features configured toengage with groove 2421 in embedded helical tissue anchor 2418, althoughother well known securement mechanisms can be employed in other exampleembodiments. Spring 2424 is also provided via guide line 2416 such thatit is captured between fastener 2420 and segment 2402. Spring 2420 canprovide various functions which can include by way of non-limitingexample: preloading segment 2402 against the embedded helical tissueanchor 2418 to reduce occurrences of the generation of potentiallyharmful wear particulates, or compensating for component manufacturingor assembly tolerances. Once implant member 2400 is secured to theembedded helical tissue anchor 2418, guide line 2416 can be decoupledfrom the embedded helical tissue anchor 2418. Decoupling can includecutting guide line 2416 or drawing guide line 2416 from an opening inembedded helical tissue anchor 2418 into which guide line 2416 islooped. It is noted that this aspect is not limited to helical tissueanchors such as helical tissue anchors 2418 and that other forms oftissue anchors may be employed. For example, FIGS. 24G and 24Hrespectively show a portion of a segment 2402 of implant member 2400before and after a coupling with a grapple tissue anchor 2500 as peranother example embodiment. Specifically, FIG. 24G shows an explodedisometric view of grapple tissue anchor 2500, the portion of segment2402 and various other components while FIG. 24H shows an assembledisometric view into which grapple tissue anchor 2500 is secured to theportion of segment 2402 of implant member 2400. In this exampleembodiment, grapple tissue anchor 2500 is secured to implant member 2400after grapple tissue anchor 2500 has been implanted or embedded intotissue. Tissue into which grapple tissue anchor 2500 is embedded is notshown for clarity.

Grapple tissue anchor 2500 includes at least two elongate members 2502 aand 2502 b (collectively elongated members 2502). Each of the elongatedmembers 2502 includes a first end 2504, a second end 2506 andintermediate portion 2508 (only one called out in FIG. 24G) positionedalong the elongate member 2502 between its first end 2504 and its secondend 2506. Each of the second ends 2506 includes a tip 2512 shaped topenetrate the tissue. Each of the intermediate portions 2508 of theelongate members 2502 is pivotably coupled together by a pivot 2510. Inthis example embodiment, each of the elongated members 2502 includes anarcuate shaped portion. Specifically, in this example embodiment, eachof the elongated members 2502 includes a portion between pivot member2510 and the second end 2506 of the elongate member that extends alongan arcuate path. In this example embodiment, each of the elongatedmembers 2502 forms a prong.

Pivot member 2510 allows the elongated members 2502 to pivot withrespect to one another to position the tips 2512 spaced relatively apartfrom one another at locations advantageous for penetrating the tissue.Upon further deployment of grapple tissue anchor 2500 into the tissue,the elongated members 2502 are pivoted relative to each other to causetips 2502 to travel along a path through the tissue such that tips 2512are positioned closer to one another than during their initialdeployment into the tissue. This allows grapple tissue anchor 2500 tofirmly anchor into the tissue. To illustrate this, FIG. 24G shows theelongate members 2502 pivoted to the opposed tips 2512 spaced such thatposition grapple tissue anchor 2500 would not be fully deployed into thetissue. Whereas FIG. 24H shows the elongate members 2502 pivoted toposition the opposed tips 2512 such that grapple tissue anchor 2500would be fully deployed into tissue. Those skilled in the art willappreciate that other deployment configurations can be employed by othergrapple tissue anchors employed by various embodiments. For example,each of the elongated members 2502 can be configured to follow adifferent path through tissue during the deployment of the grappletissue anchor 2500 into tissue. In some example embodiments, tips 2512may, or may not overlap when grapple tissue anchor 2500 is fullydeployed into tissue.

In this example embodiment, grapple tissue anchor 2500 is part of atissue anchor system that includes at least one coupler 2530 that isphysically coupled to at least one of the elongated member 2502, the atleast one coupler 2530 being additionally configured to be received byimplant member 2400 when the grapple tissue anchor 2500 is secured toimplant member 2400. In this illustrated embodiment, a guide line 2514extends from each elongated member 2502. As best shown in FIG. 24G, aguide line 2514 a extends from elongate member 2502 a and a guide line2514 b extends from elongate member 2502 b. In this example embodiment,each guide line 2514 is sized to be received through an opening 2516(only one called out in FIG. 24G). In this example embodiment, each ofthe guide lines 2514 a and 2514 b is looped through an associated one ofthe openings 2516 (e.g., eyelet). This allows each of the guide lines2514 to be releasably coupled with an associated one of the elongatedmembers 2502, the coupling being released by simply releasing an end ofthe guide line 2514 to allow it to be extracted through an associatedone of the openings 2516.

In this example embodiment, guide lines 2514 are also each sized to bereceived through tissue anchor receiver 2412 and guide line receiver2410 provided in segment 2402. In this example embodiment, guide lines2514 are received through each of tissue anchor receiver 2412 and guideline receiver 2410 after grapple tissue anchor 2500 is embedded intotissue. In this particular embodiment, the at least one coupler 2530includes a two component seat 2518 that is configured to mate or engagewith tissue anchor receiver 2412 in a similar manner to seat 2426employed by the embodiment illustrated in FIGS. 24E and 24F. Seat 2518includes a first seat component 2518 a coupled to elongated member 2502a and a second seat component 2518 b coupled to elongate member 2502 b.Each component of seat 2518 and an associated one of the elongatedmembers 2502 can be provided in a unitary structure. Alternatively, eachcomponent of seat 2518 may be secured to an associated one of theelongated members 2502 by variety of methods including, adhesives,crimping, and heat fitting, by way of non-limiting example. When grappletissue anchor 2500 is deployed into tissue, seat 2518 is configured tomate or engage with tissue anchor receiver 2412 in this illustratedexample embodiment. In this illustrated embodiment, the seat components2518 a and 2518 b include tapered surfaces configured to mate with atapered surface provided by tissue anchor receiver 2412 in a mannersimilar to that employed by the embodiment illustrated in FIGS. 24E and24F.

In this illustrated embodiment, fastener 2520 is provided via guidelines 2514 to secure segment 2402 to embedded grapple tissue anchor2500. Unlike other fasteners employed in other described embodimentsthat secure an implant member to the tissue by coupling with a guideline (e.g., fasteners 2100, 2200), fastener 2520 couples directly withthe embedded grapple tissue anchor 2500 itself as shown in FIG. 24H. Inthis illustrated embodiment, fastener 2520 includes snap-ring featuresconfigured to engage with a portion of groove 2521 provided in each ofthe elongated members 2502, when grapple tissue anchor 2500 is embeddedinto tissue. Spring 2524 is also provided via guide lines 2514 such thatit is captured between fastener 2520 and segment 2402. Spring 2520 canprovide various functions which can include by way of non-limitingexample: preloading segment 2402 against the embedded grapple tissueanchor 2500 to reduce occurrences of the generation of potentiallyharmful wear particulates, or compensating for component manufacturingor assembly tolerances. Once implant member 2400 is secured to theembedded grapple tissue anchor 2500, guide lines 2514 can be decoupledfrom the embedded grapple tissue anchor 2500.

The present embodiments are not limited to securing grapple tissueanchor 2500 to articulated implant members such as implant member 2400.Other example embodiments may employ other members or mechanisms tosecure tissue anchors such as grapple tissue anchor 2500 to an implantmember employed in an implant procedure. Without limitation, variouscouplers 2530 can be employed to couple a tissue anchor such as grappletissue anchor 2500 to an implant member. By way of non limiting example,coupler 2530 can include a clamp configured to clamp a portion of theimplant member. Coupler 2530 can include an extension sized to bereceived within an opening provided in an implant member. Coupler 2530can include an expansion member configured to expand and grip one ormore surfaces of an implant member. Coupler 2530 can include acontraction member configured to contract and grip one or more surfacesof an implant member. Coupler 2530 can include detent or a snap-actioncomponent.

FIGS. 23A-23T sequentially show an implant procedure according to oneillustrated embodiment. The implant procedure includes placement oftissue anchors via an anchor guide frame at selected locations in anannulus surrounding a mitral valve of a left atrium of a heart, and thesecurement of an implant member to the annulus via the embedded tissueanchors. Fluoroscopy, CT scanning, trans-esophageal echo (TEE) and/orother imaging or radiological techniques may be employed during all orpart of the medical procedure, for example for guiding various cathetersand/or locating the anchor guide frame for precisely placing orembedding the tissue anchors. For instance, TEE techniques may beemployed to determine when to lock the implant member in position in theimplantable configuration with the fasteners. Ultrasound may be employedbefore the medical procedure, or as part of the medical procedure, todetermine a size of the mitral valve. Such information may be employedin selecting an appropriately sized implant member or in adjusting asize of the implant member. In some instances, the implant member mayalso be selected based on the actual locations of the tissue anchors.

In particular, FIG. 23A shows a distal end 2300 of a cardiac catheter2302 advancing in a left atrium 2304 of a heart. The cardiac catheter2302 may, for example, enter the heart via an inferior vena cava (notshown) or a superior vena cava (not shown), then enter the left atriumvia a hole formed in a septum (not shown) of the heart. The cardiaccatheter 2302 may be inserted using an introducer and guide wire, as iscommonly known. A proximate end (not shown) of the cardiac catheter 2302is outside of the bodily or accessible from outside of the body.

An engagement or locating member 2306 of an anchor guide frame 2308 isvisible, extending out of the distal end 2300 of the cardiac catheter2302. The engagement or locating member 2306 may have a number of arms2306 a (three illustrated, only one called out in FIGS. 23A-23T) and ahub 2306 b. The hub 2306 b may couple the arms 2306 a. A mitral valve2310 of the heart is also visible, including an annulus 2312, which isnatural tissue that surrounds the mitral valve 2310. In use, the hub2306 b may be centered in the mitral valve 2310 in contact with thecusps or leaflets of the mitral valve 2310. The hub 2306 b may take theform of an alignment member, for instance the alignment fin 1305previously described with reference to FIG. 13.

FIG. 23B shows an anchoring catheter 2314 extending out of the cardiaccatheter 2302. The anchoring catheter 2314 carries the anchor guideframe 2308. The anchoring catheter 2314 has a steerable portion 2316,which may be selectively steered from a location outside the body. Thesteerable portion 2316 may include an articulated section. The steerableportion 2316 may be steered mechanically, for example using wires (notshown in FIGS. 23A-23T) that extend through the anchoring catheter 2314and which are attached to opposing portions of the articulated section.Alternatively, the steerable portion 2316 may be steered hydraulically,for example by controlling pressure in a number of lumens that extendthrough the anchoring catheter and which terminate in the articulatedsection. In addition to the engagement or locating member 2306, theanchor guide frame 2308 includes a number of anchor guides 2316 (threeillustrated in FIGS. 23A-23T, only one called out) which guide tissueanchors 2318 (FIGS. 23J-23T) to selected locations on the annulus 2312.The anchor guides 2316 may each include a dual lumen outer tube 2320(only one called out in FIGS. 23A-23T). One lumen may carry a respectiveone of the arms 2306 a of the engagement or locating member 2306 formovement through the lumen. The other lumen may carry an inner or guidetube 2322, the tissue anchor 2318 and a guide line or guide wire 2330(only one called out in FIGS. 23M-23T) for movement through the lumen.The inner or guide tube 2322 may be physically coupled to advance thetissue anchor 2318 through the lumen. Such a structure, and its use,were previously explained with reference to FIGS. 8C-8F.

FIG. 23C shows the anchoring catheter 2314 being steered to face themitral valve 2310. FIG. 23D shows the anchoring catheter 2314 beingadvanced toward the mitral valve 2310.

FIG. 23E shows the engagement or locating member 2306 being extendedfrom the anchoring catheter 2314 toward the mitral valve 2310. FIG. 23Fshows the anchor guide frame 2308 beginning to open or expand, a slightbow in arms 2308 a (only one called out in FIGS. 23F-23S) being visiblein FIG. 23F. The anchor guide frame 2308 is opened once the engagementor locating member 2306 or hub 2306 b is approximately in a desiredposition and orientation with respect to the mitral valve 2310. FIGS.23G and 23H show the anchor guide frame 2308 opening or expandingfurther at successive intervals. FIG. 23I shows the anchor guide frame2308 fully open or expanded. The anchor guide frame 2308 may moveautomatically into position because of the correspondence of the shapeof the anchor guide frame 2308 with the anatomical structure of thevalve. The anchor guide frame 2308 may be constructed so that the tworear most arms (as illustrated, one labeled 2306 a and other one at theback of the figure) slide into the mitral commissures. Even if theanchor guide frame 2308 is deployed at the wrong angle, expanding thelegs caused the anchor guide frame 2308 to rotate as the legs get pushedinto the commissures. The mitral annulus is not perfectly round, and“corners” of the mitral annulus can advantageously be used to cause theanchor guide frame 2308 to automatically align with the mitral valve.

FIG. 23J shows the inner or guide tubes 2322 with tissue anchors 2318beginning to protrude from the outer tubes 2320. FIGS. 23K and 23L showthe inner or guide tubes 2322 with tissue anchors 2318 protrudingfurther from the outer tubes 2320, at successive intervals, embeddingthe tissue anchors 2318 into the annulus 2312 of the mitral valve 2310.FIG. 23M shows the inner or guide tubes 2322 being withdrawn back intothe outer tubes 2320, leaving the tissue anchors 2318 embedded in thetissue of the annulus 2312. The guide line or guide wire 2330 is firstvisible in FIG. 23M. As explained in reference to FIGS. 8C-8F, the guideline or guide wire 2330 may be pushed or held in place as the inner orguide tubes 2322 are withdrawn back into the outer tube 2320. FIG. 23Nshows the inner or guide tubes 2322 almost fully withdrawn in the outertube 2320, while FIG. 23O shows the inner or guide tubes 2322 fullywithdrawn in the outer tube 2320.

FIG. 23P shows the anchor guide frame 2308 closing or collapsing. FIGS.23Q and 23R shows the closed or collapsed anchor guide frame 2308 andanchoring catheter 2314 being positioned and oriented at successiveintervals to be withdrawn into the cardiac catheter 2302. FIG. 23S showsthe anchoring catheter 2314 withdrawn into the cardiac catheter 2302,leaving the tissue anchors 2318 and guide lines or guide wires 2330behind in the left atrium 2304 of the heart. The anchoring catheter 2314may then be removed, clearing the cardiac catheter 2302 for the nextcatheter, used to deliver an implant member. After the anchoringcatheter 2314 is withdrawn from the cardiac catheter 2302, the guidelines or guide wires 2330 extend from the tissue anchors 2318 throughthe cardiac catheter 2302 at least to the proximate end thereof. Suchallows an implant member to be coupled to the guide lines or guide wires2330.

FIG. 23T shows a portion of an implant member 2332 being advanced intothe left atrium 2304 through the cardiac catheter 2302. The implantmember 2332 may take the form of an annuloplasty ring. As used hereinand in the claims, a ring or annular structure may be an open structure(e.g., C-shaped) or a closed structure (O-shaped). The implant member2332 has a number of guide line receivers 2332 a (only one illustratedin FIG. 23T) that couple the implant member 2332 to a respective guideline or guide wire 2330. In the illustrated embodiment, the guide linereceiver 2332 a takes the form of a hole or aperture, sized to receivethe guide line or guide wire 2330. Such allows the implant member 2332to ride or otherwise advance along the guide lines or guide wires 2330toward the tissue anchors 2318 embedded in the tissue around an orifice(e.g., mitral valve 2310). As previously explained in reference to FIGS.5C and 5D, the implant member 2332 may include a relief (not illustratedin FIG. 23T) proximate the guide line receiver 2332 a.

FIG. 23U shows the implant member 2332, guide lines or guide wires 2318and fasteners 2334 (only one called out in FIG. 23U), according to oneillustrated embodiment.

The implant member 2332 takes the form of an annuloplasty ring. Suitablesegmented structures for the implant member 2332 have been previouslydescribed, for example in reference to FIGS. 19A-19D, 20A-20D, and24A-24H although other implant member structures may be employed. Theimplant member 2332 is physically attached directly or coupledindirectly to the annulus 2312 of the mitral valve 2310. The implantmember 2332 encompasses or surrounds a portion of the mitral valve 2310,for example angularly surrounding approximately half of the mitral valve2310. In particular, the implant member 2332 is positioned and orientedto allow an anterior-posterior annular dimension of the mitral valve2310 to be changed, for instance reduced. Such may cause the leaflets ofthe mitral valve 2310 to better coapt.

The implant member 2332 may ride or otherwise advance along the guidelines or guide wires 2318 to the locations on the annulus 2312 where thetissue anchors 2318 are embedded. A desired position and orientation isachieved due to the ability to precisely locate the tissue anchors 2318using the anchor guide frame 2308. In particular, the engagement orlocating member 2306 or hub 2306 b and/or the anchor guides 2316 allowsprecise positioning and orientation of the embedding of the tissueanchors 1218, and hence the precise positioning and orientation of theimplant member 2332.

In this example embodiment, fasteners 2334 are advanced along each ofthe guide lines or guide wires 2330 to secure the implant member 2332 tothe annulus 2312. As previously described, the fasteners 2334 may take avariety of forms. For example, one-way clutch or cam mechanisms mayallow the fasteners 2334 to advance in one direction along the guidelines or guide wires 2330 toward the tissue anchors 2318, but prevent orresist retreat of the fasteners 2334 along the guide lines or guidewires 2330 away from the tissue anchors 2318. After the fasteners 2334are in place, excess portions of the guide lines or wires 2330 may becut, broken or otherwise severed, and the excess portions removed fromthe body via the cardiac catheter 2302. Various embodiments of suitablecutting or severing mechanisms have been described above. Alternatively,a mechanism that facilitated a twisting or flexing of the guide lines orguide wires 2330 may be employed. The guide lines or guide wires 2330are typically very fine, and may be easily severed with appropriatetwisting or rotation about a longitudinal axis thereof. A small tailpiece of guide line or guide wire 2330 may be left exposed beyond thefastener 2334 to allow later access, for example to replace the implantmember 2332. In other example embodiments, fasteners 2334 are employedto couple directly with the embedded tissue anchors 2318 to secureimplant member 2332 to the annulus 2312. In some example embodimentsimplant member 2332 and fasteners 2334 are combined into a unitarystructure.

The various embodiments described above can be combined to providefurther embodiments. All of any U.S. patents, U.S. patent applicationpublications, U.S. patent applications, foreign patents, foreign patentapplications and non-patent publications referred to in thisspecification and/or listed in the Application Data Sheet, includingU.S. patent application Ser. No. 12/894,912, field Sep. 30, 2010, andU.S. provisional patent application Ser. No. 61/278,232, filed Oct. 1,2009, are incorporated herein by reference, in their entirety. Aspectsof the various embodiments can be modified, if necessary, to employsystems, circuits and concepts of the various patents, applications andpublications to provide yet further embodiments.

These and other changes can be made in light of the above-detaileddescription. In general, in the following claims, the terms used shouldnot be construed to limit the invention to the specific embodimentsdisclosed in the specification and the claims, but should be construedto include all medical treatment devices in accordance with the claims.Accordingly, the invention is not limited by the disclosure, but insteadits scope is to be determined entirely by the following claims.

The invention claimed is:
 1. An implant kit comprising: a helical tissueanchor comprising a plurality of coils; a percutaneous delivery systemoperable to at least partially embed the helical tissue anchor into atissue insertion location in tissue within a body during an implantprocedure, the percutaneous delivery system comprising a membercomprising a lumen; and a guide rail configured to provide the helicaltissue anchor to the tissue insertion location, a portion of the guiderail located within at least some of the plurality of coils of thehelical tissue anchor at least in a state in which the guide rail is atleast partially located within the lumen of the member, wherein theguide rail comprises a bend configured to facilitate the helical tissueanchor spiraling off of the guide rail into tissue at a particularlocation spaced from an end of the guide rail via the helical tissueanchor rotating with respect to the guide rail.
 2. The implant kit ofclaim 1, wherein the portion of the guide rail and the at least some ofthe plurality of coils of the helical tissue anchor reside within thelumen of the member at least in one configuration of the percutaneousdelivery system.
 3. The implant kit of claim 1, wherein the bend formsat least a 90° angle in the guide rail.
 4. The implant kit of claim 1,wherein the bend is configured to be proximate or to contact the tissueinsertion location during the implant procedure.
 5. The implant kit ofclaim 1, wherein the guide rail comprises a first part and a second partjoined to the first part via the bend in the guide rail, and wherein atleast some of the first part of the guide rail is configured to belocated within the lumen of the member at least in a state in which atleast some of the second part of the guide rail contacts at least someof the tissue within the body.
 6. The implant kit of claim 1, whereinthe bend comprises a joint.
 7. The implant kit of claim 6, wherein thejoint comprises a hinge or a flexure.
 8. The implant kit of claim 1,wherein the bend is configured to engage the helical tissue anchor at aparticular region along the guide rail during relative translationalmovement between the helical tissue anchor and the guide rail, the bendconfigured to cause the helical tissue anchor to helically rotate inresponse to the engagement between the bend and the helical tissueanchor.
 9. The implant kit of claim 1, wherein the member comprising thelumen is provided by a single lumen push tube.
 10. The implant kit ofclaim 1, wherein the guide rail and the helical tissue anchor areconfigured to matingly engage to permit an anchor tip of the helicaltissue anchor to move along the guide rail in a manner that protects thetissue within the body away from the tissue insertion location fromcontacting the anchor tip.
 11. The implant kit of claim 1, furthercomprising a latch mechanism configured to retain the helical tissueanchor in a latched state and configured to release the helical tissueanchor in an unlatched state.
 12. The implant kit of claim 1, whereinthe member is physically coupled to the helical tissue anchor to causethe helical tissue anchor to helically rotate in response to rotation ofthe member.
 13. The implant kit of claim 1, wherein the member isphysically coupled to the helical tissue anchor to cause the helicaltissue anchor to rotate in response to rotation of the member about aportion of the guide rail located within the lumen of the member. 14.The implant kit of claim 1, wherein the member is removably coupled tothe helical tissue anchor to allow the member to decouple from thehelical tissue anchor at least in a state after the helical tissueanchor has been embedded into the tissue insertion location in tissuewithin the body.
 15. A method of operating a medical device, the methodcomprising: delivering a helical tissue anchor of the medical devicealong a guide rail of the medical device through at least a portion of alumen of a member of the medical device, the helical tissue anchorcomprising a plurality of coils surrounding a portion of the guide railduring the delivering; and releasing the helical tissue anchor from theguide rail at least in a state in which the guide rail is partiallylocated outside of the lumen of the member and partially located insidethe lumen of the member, wherein the releasing includes a bend in theguide rail causing the helical tissue anchor to spiral off of the guiderail at a particular location spaced from an end of the guide rail in amanner configured to deliver the helical tissue anchor into tissue viathe helical tissue anchor rotating with respect to the guide rail. 16.The method of claim 15, wherein the bend in the guide rail is located atleast proximate the particular location where the helical tissue anchorspirals off of the guide rail.
 17. The method of claim 16, wherein thebend forms at least a 90° angle in the guide rail.
 18. The method ofclaim 16, wherein the bend is configured to be proximate, or in contactwith, tissue during the spiraling the helical tissue anchor off of theguide rail.
 19. The method of claim 16, wherein the bend comprises ajoint.
 20. The method of claim 19, wherein the joint comprises a hingeor a flexure.
 21. The method of claim 15, comprising: causing relativetranslational movement between the helical tissue anchor and the guiderail to cause engagement between the bend and the helical tissue anchorat a particular region along the guide rail, wherein the rotating of thehelical tissue anchor with respect to the guide rail occurs at least inresponse to the engagement between the bend and the helical tissueanchor.
 22. The method of claim 21, wherein the particular location atwhich the helical tissue anchor spirals off of the guide rail is theparticular region of engagement between the bend and the helical tissueanchor.
 23. The method of claim 21, wherein the bend forms at least a90° angle in the guide rail.
 24. The method of claim 21, wherein thebend is configured to be proximate, or in contact with, tissue duringthe spiraling of the helical tissue anchor off of the guide rail. 25.The method of claim 21, wherein the guide rail comprises a first partand a second part joined to the first part via the bend in the guiderail, and wherein, during the spiraling of the helical tissue anchor offof the guide rail, at least some of the first part of the guide rail islocated within the lumen of the member and at least some of the secondpart of the guide rail is located outside of the lumen of the member.26. The method of claim 21, wherein the bend comprises a joint.
 27. Themethod of claim 26, wherein the joint comprises a hinge or a flexure.28. The method of claim 15, wherein the member comprising the lumen isprovided by a single lumen push tube.
 29. The method of claim 15,wherein the member is physically coupled to the helical tissue anchor tocause the helical tissue anchor to helically rotate in response torotation of the member.
 30. The method of claim 15, wherein the memberis physically coupled to the helical tissue anchor to cause the helicaltissue anchor to rotate in response to rotation of the member about aportion of the guide rail located within the lumen of the member. 31.The method of claim 15, wherein the helical tissue anchor is configuredto be released from the guide rail at least in a state after the helicaltissue anchor has been embedded into tissue.